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Clinical Trial Details

Trial ID: L2802
Source ID: NCT01547104
Associated Drug: Linagliptin
Title: Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Linagliptin|DRUG: Glimepiride
Outcome Measures: Primary: Postprandial increase in intact Proinsulin levels (Peak, AUC), 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment|Postprandial Proinsulin/Insulin Ratio, after 12 weeks treatment|Fasting intact Proinsulin levels, after 12 weeks treatment|Fasting Proinsulin/Insulin Ratio, after 12 weeks treatment|Fasting Blood Glucose, after 12 weeks treatment|Postprandial Blood Glucose Excursions (Peak; AUC), 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment|Fasting Lipids, after 12 weeks treatment|Postprandial Lipids, after 12 weeks treatment|Fasting Erythrocyte Flexibility, after 12 weeks treatment|Postprandial Erythrocyte Flexibility, after 12 weeks treatment|Fasting GLP-1 levels, after 12 weeks treatment|Postprandial GLP-1 levels, after 12 weeks treatment|Fasting cGMP, after 12 weeks treatment|Postprandial cGMP, after 12 weeks treatment|Fasting Calcitonin, after 12 weeks treatment|Fasting PAI-1 levels, after 12 weeks treatment|Postprandial PAI-1 levels, after 12 weeks treatment|Fasting ADMA levels, after 12 weeks treatment|Postprandial ADMA levels, after 12 weeks treatment|Fasting Malonyldialdehyd, after 12 weeks treatment|fasting oxidatively modified nucleosides 8-oxodG and 8-oxoGuo, after 12 weeks treatment | Secondary: Hypoglycemic events, after 12 weeks treatment|Body Weight, after 12 weeks treatment
Sponsor/Collaborators: Sponsor: Marcus Borchert | Collaborators: ikfe-CRO GmbH|Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2012-04
Completion Date: 2012-10
Results First Posted:
Last Update Posted: 2012-04-11
Locations: ikfe GmbH, Mainz, Rhineland-Palatinate, 55116, Germany
URL: https://clinicaltrials.gov/show/NCT01547104