Clinical Trial Details
Trial ID: | L3203 |
Source ID: | NCT00118963 |
Associated Drug: | Metformin |
Title: | Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes |
Acronym: | |
Status: | COMPLETED |
Study Results: | NO |
Results: | |
Conditions: | Diabetes Mellitus, Type 2 |
Interventions: | DRUG: Metformin|DRUG: Insulin BIAsp30 (Novolog 70/30)|DRUG: Repaglinide|DRUG: Placebo-Metformin|DRUG: Placebo-Repaglinide |
Outcome Measures: | Primary: Glycemic control (HbA1c). | Secondary: Hypoglycaemic events|Home monitored plasma-glucose profiles|Insulin-dose|Non-glycemic cardiovascular risk factors: 24h blood-pressure measurement|24h urinary albumin excretion-rate.|Fasting and postprandial 5-point-profiles of total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, free fatty acids, p-glucose, c-peptide and insulin after a standard test-meal|Markers of endothelial dysfunction, inflammation and fibrinolysis including Small-dense-LDL, Lp(a) and Apo B100, von Willebrand-factor, ICAM, VCAM, selectin, endothelin, Amadori-protein, CRP, fibrinogen, IL-6, TNF-alfa, ADMA, PAI- and t-PA-activity |
Sponsor/Collaborators: | Sponsor: Steno Diabetes Center Copenhagen |
Gender: | ALL |
Age: | ADULT, OLDER_ADULT |
Phases: | PHASE4 |
Enrollment: | 102 |
Study Type: | INTERVENTIONAL |
Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
Start Date: | 2003-01 |
Completion Date: | 2006-02 |
Results First Posted: | |
Last Update Posted: | 2008-12-08 |
Locations: | Steno Diabetes Center, Gentofte, 2820, Denmark |
URL: | https://clinicaltrials.gov/show/NCT00118963 |