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Clinical Trial Details

Trial ID: L3824
Source ID: NCT02304081
Associated Drug: Saxagliptin
Title: Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin|DRUG: Placebo for Saxagliptin
Outcome Measures: Primary: Glucagon / insulin ratio during hyperglycaemic clamp phase (AUCGluc270-390min / AUCIns270-390min), at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days) | Secondary: Glucagon release during hyperglycaemic clamp phase (AUCGluc270-390min; pg/ml*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|First phase glucagon release during hyperglycaemic clamp phase (AUCGluc270-290min; pg/ml*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|First phase insulin release during hyperglycaemic clamp phase (AUCIns270-290min; pmol/l*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Second phase insulin release during hyperglycaemic clamp phase (AUCIns290-390min; pmol/l*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|First Phase glucagon / insulin ratio during hyperglycaemic clamp phase (AUCGluc270-290min / AUCIns270-290min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Second Phase glucagon / insulin ratio during hyperglycaemic clamp phase (AUCGluc290-390min / AUCIns290-390min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Intact proinsulin release during hyperglycaemic clamp (AUCIP270-390min ; pmol/l*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Insulin / proinsulin ratio during hyperglycaemic clamp (AUCIns270-390min / AUCIP270-390min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|C-Peptide release during hyperglycaemic clamp (AUCC-Pep270-390min ; pmol/l*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|C-Peptide/Insulin ratio during hyperglycaemic clamp (AUCC-Pep270-390min / AUCIP270-390min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|M-Value during euglycaemic-hyperinsulinaemic clamp phase (mg/kg*min), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|HOMAIR Index, Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Body Weight (kg), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Fasting Adiponectin (µg/ml), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Fasting Plasma Glucose (mg/dl), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|HbA1C (mmol/mol; %), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|QuantoseTM Score, Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)|Blood Lipids (Triglycerides [mg/dl]; total, HDL, LDL cholesterol [mg/dl]), Pharmacodynamic endpoints, at baseline (Day 0) as well as after Treatment Phase 1 (after 30 days) and after Treatment Phase 2 (after 60 days)
Sponsor/Collaborators: Sponsor: Prof. Dr. Thomas Forst
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2016-08
Results First Posted:
Last Update Posted: 2018-06-20
Locations: Profil Mainz GmbH & Co. KG, Mainz, 55116, Germany
URL: https://clinicaltrials.gov/show/NCT02304081