Insulin ( DrugBank: - )
6 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 4 |
| 13 | 多発性硬化症／視神経脊髄炎 | 4 |
| 46 | 悪性関節リウマチ | 6 |
| 75 | クッシング病 | 6 |
| 78 | 下垂体前葉機能低下症 | 25 |
| 299 | 嚢胞性線維症 | 24 |
6. パーキンソン病
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05266417 (ClinicalTrials.gov) | February 7, 2022 | 23/2/2022 | Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD) | Parkinson Disease | Drug: INS-GSH;Drug: Matched Placebos | Gateway Institute for Brain Research | NULL | Recruiting | 30 Years | 85 Years | All | 56 | Phase 2 | United States |
| 2 | NCT04251585 (ClinicalTrials.gov) | February 4, 2020 | 28/1/2020 | Intranasal Insulin in Parkinson's Disease | Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease | Parkinson Disease | Drug: Regular Novolin R;Drug: Placebo | HealthPartners Institute | NULL | Recruiting | 41 Years | 89 Years | All | 30 | Phase 2 | United States |
| 3 | NCT04687878 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2020 | The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients | Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial | Parkinson Disease | Drug: Insulin;Drug: Normal saline | dr.dargahi | NULL | Recruiting | 17 Years | N/A | All | 40 | Phase 2 | Iran, Islamic Republic of |
| 4 | NCT02064166 (ClinicalTrials.gov) | February 2014 | 13/2/2014 | Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin. | A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy | Parkinson Disease;Multiple System Atrophy | Drug: Intranasal Insulin | Peter Novak | NULL | Completed | 18 Years | N/A | All | 15 | Phase 2 | United States |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-003001-94-SK (EUCTR) | 06/11/2019 | 13/09/2019 | Use of GLP-1 analogs in the treatment of multiple sclerosis | Use of GLP-1 analogs in the treatment of multiple sclerosis - MSGLP | Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere. Product Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere | Lekárska fakulta UK Bratislava | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Slovakia | ||
| 2 | NCT02988401 (ClinicalTrials.gov) | December 1, 2017 | 7/12/2016 | Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis | Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive | Drug: Insulin;Drug: Placebo (Sterile diluent) | Johns Hopkins University | United States Department of Defense | Completed | 18 Years | 70 Years | All | 105 | Phase 1/Phase 2 | United States |
| 3 | NCT03052595 (ClinicalTrials.gov) | February 1, 2017 | 10/2/2017 | Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance | Multiple Sclerosis: The Role of Mitochondrial Dysfunction in Insulin Resistance | Multiple Sclerosis;Mitochondrial Alteration | Diagnostic Test: Oral glucose tolerance test;Diagnostic Test: Testing of autonomous nervous system function;Diagnostic Test: Stroop test | Slovak Academy of Sciences | Comenius University | Recruiting | 18 Years | 45 Years | All | 70 | Slovakia | |
| 4 | NCT00001669 (ClinicalTrials.gov) | July 1997 | 3/11/1999 | A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients | A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients | Multiple Sclerosis | Drug: rhIGF-1 (CEP-151) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 15 | Phase 2 | United States |
46. 悪性関節リウマチ
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03394131 (ClinicalTrials.gov) | July 1, 2017 | 25/12/2017 | ?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients | Treatment of Carpal Tunnel in Rheumatoid Arthritis | Treatment Resistant Carpal Tunnel in RA Patients | Drug: Hylase;Drug: Insulin;Other: saline | Assiut University | NULL | Unknown status | 20 Years | 80 Years | All | 90 | N/A | Egypt |
| 2 | NCT02535832 (ClinicalTrials.gov) | September 2015 | 24/8/2015 | Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) | Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) | Rheumatoid Arthritis;Insulin Resistance | Drug: Pioglitazone;Drug: Placebo | Ohio State University | NULL | Recruiting | 35 Years | 65 Years | All | 36 | Phase 1 | United States |
| 3 | NCT01132118 (ClinicalTrials.gov) | June 2010 | 25/5/2010 | Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis | Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis | Rheumatoid Arthritis;Insulin Resistance | Drug: Hydroxychloroquine | Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 18 Years | N/A | All | 30 | Phase 3 | United States |
| 4 | NCT00763139 (ClinicalTrials.gov) | April 2009 | 26/9/2008 | Inflammation and Insulin Resistance in Rheumatoid Arthritis | Inflammation and Insulin Resistance in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Pioglitazone;Drug: Placebo | Vanderbilt University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 18 Years | N/A | All | 34 | N/A | United States |
| 5 | EUCTR2005-000492-18-IT (EUCTR) | 16/12/2004 | 09/11/2007 | Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome | Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome | Metabolic Syndrome and Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10021428 | Trade Name: REMICADE*EV F 100MG+F 2ML INN or Proposed INN: Infliximab | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 6 | NCT00034060 (ClinicalTrials.gov) | April 2002 | 19/4/2002 | The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept | Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis | Rheumatoid Arthritis;Healthy | Drug: Etanercept | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Completed | N/A | N/A | Female | 36 | Phase 2 | United States |
75. クッシング病
臨床試験数 : 203 / 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-002916-16-PL (EUCTR) | 29/06/2015 | 16/03/2015 | Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: pasireotide pamoate Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE PAMOATE Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE PAMOATE Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Phase 4 | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 2 | EUCTR2012-002916-16-BE (EUCTR) | 04/05/2015 | 31/03/2015 | Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 17.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 17.1;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE Trade Name: Signifor Product Name: pasireotide LAR Product Code: SOM230 LAR INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 4 | United States;Spain;Thailand;Turkey;Russian Federation;India;Poland;Belgium;Brazil;Romania;Denmark;Peru;Bulgaria;Germany;Netherlands;China | ||
| 3 | EUCTR2012-002916-16-DE (EUCTR) | 19/08/2014 | 17/03/2014 | Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 300micrograms INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 600 micrograms INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 900 micrograms INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE DIASPARTATE Product Name: pasireotide LAR Product Code: SOM230 LAR, 20 mg INN or Proposed INN: PASIREOTIDE Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 4 | EUCTR2012-002916-16-DK (EUCTR) | 01/07/2014 | 09/04/2014 | Study of management of pasireotide-induced hyperglycemiain adult patients with Cushing’s disease or acromegaly | A multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushing’s disease or acromegaly. | Cushing's disease and acromegaly MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: SOM230B Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide LAR Product Code: SOM230 LAR Other descriptive name: PASIREOTIDE PAMOATE Product Name: pasireotide LAR Product Code: SOM230 LAR Other descriptive name: PASIREOTIDE PAMOATE Product Name: pasireotide LAR Product Code: SOM230 LAR Other descriptive name: PASIREOTIDE PAMOATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Phase 4 | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 5 | NCT02060383 (ClinicalTrials.gov) | May 23, 2014 | 10/2/2014 | Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly | A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly | Cushing's Disease;Acromegaly | Drug: Pasireotide s.c.;Drug: Sitagliptin;Drug: Liraglutide;Drug: Insulin;Drug: Pasireotide LAR;Drug: Metformin | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 249 | Phase 4 | United States;Belgium;Brazil;China;Denmark;Germany;India;Peru;Poland;Russian Federation;Thailand;Turkey |
| 6 | NCT03080181 (ClinicalTrials.gov) | May 2013 | 3/3/2017 | Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment | Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters | Cushing Disease | Drug: Pasireotide 0.6 MG/ML | University of Palermo | NULL | Completed | 18 Years | N/A | All | 24 | Phase 4 | NULL |
78. 下垂体前葉機能低下症
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-002337-22-IT (EUCTR) | 24/05/2016 | 08/06/2021 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: Macimorelin acetate Trade Name: Humalog Mix50 100 U/ml sospensione iniettabile Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: Insulin | AETERNA ZENTARIS GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | France;United States;Serbia;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2015-002337-22-PL (EUCTR) | 12/04/2016 | 01/02/2016 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;France;United States;Spain;Poland;Austria;Germany;Italy;United Kingdom | ||
| 3 | NCT02782208 (ClinicalTrials.gov) | February 10, 2016 | 18/5/2016 | Lipolytic Effects of GH in Hypopituitary Patients in Vivo | Lipolytic Effects of GH in Hypopituitary Patients in Vivo: Molecular Mechanisms and Temporal Patterns. | Hypopituitarism;Insulin Resistance;Endocrine System Diseases;Glucose Metabolism Disorders;Metabolic Diseases;Pituitary Diseases;Brain Diseases | Drug: Acipimox;Drug: Placebo;Drug: GH substitution;Other: GH pause | University of Aarhus | NULL | Completed | 18 Years | 70 Years | Male | 9 | N/A | Denmark |
| 4 | EUCTR2015-002337-22-DE (EUCTR) | 19/01/2016 | 09/11/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2015-002337-22-AT (EUCTR) | 10/12/2015 | 30/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2015-002337-22-GB (EUCTR) | 08/12/2015 | 28/10/2015 | Comparison of the substance macimorelin (drinking solution) with insulin (injection) to confirm that it works as diagnostic test for lacking growth hormone in adults | Confirmatory validation of oral macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the diagnosis of Adult Growth Hormone Deficiency (AGHD) in comparison with the Insulin Tolerance Test (ITT) - Validation of macimorelin as a test for Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency (AGHD);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Macimorelin Product Code: AEZS-130 INN or Proposed INN: Macimorelin acetate Other descriptive name: MACIMORELIN ACETATE Product Name: Insulin INN or Proposed INN: Insulin Other descriptive name: INSULIN | Aeterna Zentaris GmbH | NULL | Not Recruiting | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;France;United States;Poland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 7 | NCT02558829 (ClinicalTrials.gov) | December 3, 2015 | 21/9/2015 | Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency | Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT) | Growth Hormone Deficiency With Pituitary Anomalies | Drug: Macimorelin;Drug: Insulin | AEterna Zentaris | NULL | Completed | 18 Years | 65 Years | All | 157 | Phase 3 | United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom |
| 8 | NCT02360046 (ClinicalTrials.gov) | January 2015 | 16/1/2015 | The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism | The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids (Intrahepatocellular IHCL and Intramyocellular IMCL) in Patients With Corticotropic Hypopituitarism, a Randomised Placebo-controlled Double-blind Trial | Hypopituitarism;Hydrocortisone;Lipids;Fatty Acids, Nonesterified;Insulin Sensitivity | Drug: Hydrocortisone;Drug: Placebo | University Hospital Inselspital, Berne | NULL | Terminated | 18 Years | N/A | All | 30 | N/A | Switzerland |
| 9 | NCT01209416 (ClinicalTrials.gov) | June 2012 | 24/9/2010 | The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin | The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin | Metabolism;Insulin Resistance;Hypopituitarism | Drug: Acipimox;Drug: Ghrelin;Other: Placebo | University of Aarhus | NULL | Completed | 18 Years | 65 Years | Male | 8 | N/A | Denmark |
| 10 | NCT01467193 (ClinicalTrials.gov) | August 2011 | 3/11/2011 | The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. | The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. | Ectopic Lipids;Insulin Sensitivity;Aerobic Exercise;Fat Load;Growth Hormone Deficiency | Dietary Supplement: Fat diet;Other: 2h standardized aerobic exercise | University Hospital Inselspital, Berne | Swiss National Science Foundation | Completed | 18 Years | 80 Years | All | 30 | Switzerland | |
| 11 | EUCTR2010-020742-10-GB (EUCTR) | 09/05/2011 | 04/11/2010 | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 12 | NCT01804413 (ClinicalTrials.gov) | March 2011 | 18/2/2013 | Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency | Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study | Adults Growth Hormone Deficiency. | Drug: Pegvisomant;Drug: Regular insulin | Oregon Health and Science University | Aarhus University Hospital | Recruiting | 21 Years | 55 Years | Both | 10 | N/A | United States |
| 13 | EUCTR2010-020742-10-SE (EUCTR) | 23/02/2011 | 19/11/2010 | Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW]. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 14 | EUCTR2010-020742-10-FI (EUCTR) | 10/01/2011 | 22/11/2010 | Comparison of efficacy and safety of Nutropin (rhGH) associated with Increlex (rhIGF-1) vs Nutropin (rhGH) alone [COGROW]. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGHDose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and with poor response after one year of treatment. MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin Trade Name: INCRELEX 10 mg/ml INN or Proposed INN: Mecasermin Trade Name: NutropinAq 10 mg/2 ml INN or Proposed INN: Somatropin | Ipsen Pharma | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | ||
| 15 | NCT01282164 (ClinicalTrials.gov) | January 2011 | 19/1/2011 | The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis | The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis | Adult Growth Hormone Deficiency;Hypothalamic-pituitary Disorders | Procedure: Glucagon stimulation test and insulin tolerance test;Procedure: glucagon stimulation test and insulin tolerance test | The Cleveland Clinic | Massachusetts General Hospital;Allegheny Endocrinology Associates;Oregon Health and Science University | Completed | 18 Years | 80 Years | All | 43 | N/A | United States |
| 16 | EUCTR2010-019296-30-GB (EUCTR) | 18/05/2010 | 16/04/2010 | A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degree relatives. - ALS deficiency: insulin resistance, bone strength & response to rhIGF1 | ALS (acid label subunit) deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth Hormone Deficiency | Trade Name: INCRELEX Product Name: Increlex | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 17 | EUCTR2009-016783-37-SE (EUCTR) | 07/01/2010 | 16/10/2009 | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | Growth hormone deficiency in adults | Product Name: Genotropin, Genotropin MiniQuick Product Code: H01AC01 INN or Proposed INN: recombinant human growth hormone | Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 18 | NCT00646815 (ClinicalTrials.gov) | March 2008 | 19/2/2008 | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone (genotropin) | University of Aarhus | Aarhus University Hospital | Completed | 18 Years | 60 Years | Both | 24 | N/A | Denmark |
| 19 | NCT00491582 (ClinicalTrials.gov) | July 2007 | 25/6/2007 | The Effects of Growth Hormone (GH) on Lipid Depots | The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance | Growth Hormone Deficiency | Drug: Growth hormone replacement therapy in growth hormone deficient patients only. | University Hospital Inselspital, Berne | Swiss National Science Foundation | Completed | 18 Years | 80 Years | Both | 34 | N/A | Switzerland |
| 20 | EUCTR2005-004316-73-GB (EUCTR) | 23/08/2006 | 12/12/2005 | The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity | The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity | Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan) | Product Name: strontium ranelate Product Code: strontium ranelate INN or Proposed INN: strontium ranelate Other descriptive name: N/A Product Name: Phosphate sandoz Product Code: phosphate sandoz INN or Proposed INN: phosphate sandoz Other descriptive name: N/A Product Name: growth hormone Product Code: growth hormone INN or Proposed INN: growth hormone Other descriptive name: N/A | Royal Liverpool University hospital | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 21 | NCT00517062 (ClinicalTrials.gov) | January 2006 | 15/8/2007 | Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates | Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient Adults | Growth Hormone Deficiency | Drug: Growth hormone (Genotropin);Drug: Placebo | Oregon Health and Science University | NULL | Completed | 18 Years | 75 Years | Both | 16 | Phase 0 | United States |
| 22 | NCT00468624 (ClinicalTrials.gov) | December 2004 | 2/5/2007 | Effect of Pegvisomant on GH/IGF-I Relationship in GHD | A Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD) | Severe Adult Growth Hormone Deficiency | Drug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limb | Christie Hospital NHS Foundation Trust | NULL | Terminated | 18 Years | 70 Years | Both | N/A | United Kingdom | |
| 23 | NCT00459940 (ClinicalTrials.gov) | September 2004 | 12/4/2007 | The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients | Can Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists? | Growth Hormone Deficiency | Drug: Pioglitazone | University of Aarhus | NULL | Completed | 19 Years | 71 Years | Male | 20 | N/A | Denmark |
| 24 | NCT01060488 (ClinicalTrials.gov) | January 2004 | 29/1/2010 | Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency | A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency | Other: GHRH+Arg, GHRH+Arg, ITT;Other: ITT, ITT, GHRH+Arg. | Merck KGaA | NULL | Completed | 18 Years | 60 Years | Both | 69 | Phase 3 | France |
| 25 | NCT00929799 (ClinicalTrials.gov) | November 2003 | 29/6/2009 | Growth Hormone and Glucose Metabolism | Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: recombinant human Growth Hormone (Genotropin® ) | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | Both | 6 | Phase 4 | Germany |
299. 嚢胞性線維症
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04731272 (ClinicalTrials.gov) | April 20, 2021 | 26/1/2021 | GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance | Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial | Cystic Fibrosis;Pancreatic Insufficiency;Abnormal Glucose Tolerance;Diabetes | Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen | University of Pennsylvania | Children's Hospital of Philadelphia | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 2 | NCT04533646 (ClinicalTrials.gov) | March 17, 2021 | 23/8/2020 | Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes | Comparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related Diabetes | Cystic Fibrosis-related Diabetes | Drug: Insulin;Device: Continuous glucose monitor (CGM) | Jagdeesh Ullal | Wake Forest University Health Sciences | Recruiting | 18 Years | 80 Years | All | 20 | Phase 4 | United States |
| 3 | NCT04381429 (ClinicalTrials.gov) | August 17, 2020 | 30/4/2020 | Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes | Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial | Cystic Fibrosis-related Diabetes | Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP);Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | France |
| 4 | NCT02496780 (ClinicalTrials.gov) | August 2015 | 18/6/2015 | The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients | The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients | Cystic Fibrosis | Drug: novolog insulin;Drug: levemir insulin;Drug: placebo | University of Minnesota | NULL | Active, not recruiting | 10 Years | 25 Years | All | 66 | Phase 2/Phase 3 | United States |
| 5 | NCT01879228 (ClinicalTrials.gov) | June 2013 | 12/6/2013 | Effect of Chronic Incretin-based Therapy in Cystic Fibrosis | A Randomized, Double-blind, Placebo Controlled Study of the Effectiveness of Chronic Incretin-based Therapy on Insulin Secretion in Cystic Fibrosis | Cystic Fibrosis;Pancreatic Insufficiency | Drug: Sitagliptin | University of Pennsylvania | Children's Hospital of Philadelphia | Completed | 18 Years | N/A | All | 26 | N/A | United States |
| 6 | NCT01852448 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Genetics of Insulin and Incretins in Cystic Fibrosis | Evaluation of the Enteroinsular Axis in Cystic Fibrosis | Cystic Fibrosis | Genetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation tests | Children's Hospital of Philadelphia | University of Pennsylvania | Active, not recruiting | 2 Years | N/A | All | 550 | United States | |
| 7 | EUCTR2012-002880-86-GB (EUCTR) | 25/01/2013 | 09/11/2012 | Resting the pancreas in Cystic Fibrosis | PRESERVING ?ETA-CELLS: ‘RESTING THE PANCREAS’ IN CYSTIC FIBROSIS | Cystic Fibrosis Related Diabetes (CFRD) MedDRA version: 14.1;Level: LLT;Classification code 10022468;Term: Insulin;System Organ Class: 100000004848;Therapeutic area: Body processes [G] - Physiological processes [G07] | Trade Name: Levemir FlexPen Product Name: Levemir FlexPen | Liverpool Heart and Chest Hospital NHS Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 8 | EUCTR2011-001916-69-NL (EUCTR) | 22/05/2012 | 07/02/2012 | treatment with insulin in patients with cystic fibrosis without diabetes | insulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRD | cystic fibrosis patients without cystic fibrosis related diabetes;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Lantus 100 units/ml solution for injection in a cartridge | HagaZiekenhuis, pulmonary department | NULL | Not Recruiting | Female: yes Male: yes | 40 | Netherlands | |||
| 9 | EUCTR2011-002719-27-IT (EUCTR) | 30/12/2011 | 13/03/2012 | EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUS | GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS | PATIENTS WITH CYSTIC FIBROSIS MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML INN or Proposed INN: MECASERMIN | AZIENDA OSPEDALIERA DI PARMA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Italy | |||
| 10 | NCT01100892 (ClinicalTrials.gov) | December 2010 | 31/3/2010 | Cystic Fibrosis - Insulin Deficiency, Early Action | Cystic Fibrosis - Insulin Deficiency, Early Action | Cystic Fibrosis;Diabetes | Drug: Once-daily insulin detemir | Sydney Children's Hospitals Network | John Hunter Children's Hospital;Lady Cilento Children's Hospital, Brisbane;Women's and Children's Hospital, Adelaide;Children's Hospital Colorado | Recruiting | 5 Years | 19 Years | All | 100 | Phase 3 | United States;Australia |
| 11 | NCT01149005 (ClinicalTrials.gov) | June 2010 | 9/6/2010 | Cystic Fibrosis (CF) Exacerbation and Insulin Treatment | Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation | Cystic Fibrosis;Impaired Glucose Tolerance;Pulmonary Exacerbation | Drug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk) | Hadassah Medical Organization | NULL | Not yet recruiting | 10 Years | N/A | Both | 30 | N/A | Israel |
| 12 | EUCTR2009-009875-37-NL (EUCTR) | 11/03/2009 | 21/01/2009 | A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD | A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD | Cystic fibrosis-related diabetes MedDRA version: 9.1;Level: HLT;Classification code 10012602;Term: Diabetes mellitus (incl subtypes) MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Metformine HCL 500 PCH | Staf Longziekten | NULL | Not Recruiting | Female: yes Male: yes | 25 | Netherlands | |||
| 13 | EUCTR2007-004956-35-GB (EUCTR) | 27/08/2008 | 26/11/2007 | The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards | The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards | Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10010953;Term: COPD exacerbation MedDRA version: 9.1;Classification code 10060439;Term: Stress induced hyperglycaemia MedDRA version: 9.1;Classification code 10022484;Term: Insulin hypoglycaemia MedDRA version: 9.1;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen Trade Name: NovoRapid 100 U/ml, solution for injection in a vial. NovoRapid Penfill 100 U/ml, solution for injection in a cartridge. NovoRapid FlexPen 100 U/ml, solution for injection in a pre-filled pen. Trade Name: Lantus® 100 Units/ml solution for injection in a vial. Lantus® 100 Units/ml solution for injection in a cartridge. Lantus® 100 Units/ml solution for injection in a pre-filled pen | St George's, University of London | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 14 | NCT00639626 (ClinicalTrials.gov) | August 2008 | 14/3/2008 | Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD) | Use of Levemir® Improves Metabolic and Clinical Status in CFRD | Cystic Fibrosis Related Diabetes | Drug: insulin detemir [rDNA origin] injection | Nationwide Children's Hospital | Novo Nordisk A/S | Terminated | 16 Years | 45 Years | All | 6 | Phase 2/Phase 3 | United States |
| 15 | EUCTR2006-001254-27-FR (EUCTR) | 30/11/2006 | 25/08/2006 | Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus | Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus | Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO) MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES | Trade Name: NovoNorm 0.5 mg Product Name: NovoNorm 0.5 mg INN or Proposed INN: Répaglinide Trade Name: Actrapid Penfill 100UI/ml Product Name: Actrapid Penfill 100UI/ml INN or Proposed INN: Insuline humaine recombinante Trade Name: NovoNorm 1 mg Product Name: NovoNorm 1 mg INN or Proposed INN: Répaglinide Trade Name: NovoNorm 2 mg Product Name: NovoNorm 2 mg INN or Proposed INN: Répaglinide | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 16 | EUCTR2005-002997-31-GB (EUCTR) | 10/08/2006 | 09/11/2005 | A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes | A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes | Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes. | Product Name: Levemir Penfill | Sheffield Children's NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 17 | NCT00287456 (ClinicalTrials.gov) | February 2, 2006 | 2/2/2006 | Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients. | Cystic Fibrosis Related Diabetes | Device: Insulin Pump;Drug: Insulin;Procedure: Oral Glucose Tolerance Test;Procedure: Whole body Protein Turnover | University of Texas Southwestern Medical Center | NULL | Withdrawn | 12 Years | 32 Years | All | 0 | N/A | United States | |
| 18 | NCT00231192 (ClinicalTrials.gov) | October 2005 | 3/10/2005 | Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes | Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes | Diabetes | Drug: Repaglinide and Insulin | Children's Hospital of Philadelphia | NULL | Withdrawn | 12 Years | 20 Years | Both | 0 | N/A | United States |
| 19 | NCT00687466 (ClinicalTrials.gov) | August 2005 | 27/5/2008 | Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay | Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay | Cystic Fibrosis;Glucose Intolerance | Drug: Insulin | Fondazione per la ricerca sulla Fibrosi Cistica | NULL | Active, not recruiting | 10 Years | 70 Years | Both | 70 | Phase 3 | Italy |
| 20 | EUCTR2005-002135-27-IT (EUCTR) | 06/07/2005 | 28/06/2005 | Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration | Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration | Cystic Fibrosis patients with glucose intolerance MedDRA version: 6.1;Level: PT;Classification code 10011762 | Trade Name: LANTUS*SC 5CAR3ML100UI/ML Product Name: NA Product Code: NA INN or Proposed INN: Insulin glargine | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 21 | NCT00222521 (ClinicalTrials.gov) | April 2003 | 14/9/2005 | Insulin Glargine Vs Standard Insulin Therapy | Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia | Cystic Fibrosis Related Diabetes | Drug: Glargine insulin | University of Minnesota - Clinical and Translational Science Institute | Sanofi;Moran, Antoinette, M.D. | Completed | 12 Years | N/A | Both | 20 | Phase 3 | United States |
| 22 | NCT00662714 (ClinicalTrials.gov) | September 2001 | 17/4/2008 | Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis | Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus | Cystic Fibrosis;Diabetes Mellitus | Drug: Repaglinide;Drug: short-acting Insulin (Actrapid) | Mukoviszidose Institut gGmbH | Novo Nordisk A/S;Mucoviscidose-ABCF2;Assistance Publique - Hôpitaux de Paris | Completed | 10 Years | N/A | Both | 73 | Phase 3 | Austria;France;Germany;Italy |
| 23 | NCT00072904 (ClinicalTrials.gov) | June 2001 | 12/11/2003 | Diabetes Therapy to Improve BMI and Lung Function in CF | Diabetes Therapy to Improve BMI and Lung Function in CF | Cystic Fibrosis;Diabetes Mellitus | Drug: Insulin Asparte;Drug: Repaglinide | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Cystic Fibrosis Foundation Therapeutics;Novo Nordisk A/S | Completed | 16 Years | N/A | Both | 108 | Phase 3 | United States;Canada |
| 24 | NCT00014768 (ClinicalTrials.gov) | February 2001 | 10/4/2001 | Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis | Cystic Fibrosis | Drug: glucose;Drug: insulin;Drug: leucine | National Center for Research Resources (NCRR) | University of Utah | Terminated | N/A | N/A | Female | 36 | N/A | United States |