Clinical Trial Details
| Trial ID: | L4835 |
| Source ID: | NCT00118950 |
| Associated Drug: | Metformin |
| Title: | Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Metformin|DRUG: Repaglinide|DRUG: Placebo-Metformin.|DRUG: Placebo-Repaglinide.|OTHER: Diet-only. |
| Outcome Measures: | Primary: HaemoglobinA1c | Secondary: Home-monitored 7-point plasma-glucose profiles|Body-weight|Waist- and hip-circumference|Fasting and postprandial (after a standard test-meal) measures of plasma-glucose, insulin, c-peptide, free fatty acids, lipoproteins, triglycerides and other markers related to lipid-metabolism (e.g. apo-lipoproteins, lipoprotein particle size etc.).|Biomarkers related to inflammation, endothelial dysfunction and fibrinolysis (e.g. hs-CRP, TNF-alpha, IL-6, ICAM, VCAM, E-selectin, vWF, PAI-1 and t-PA, adiponectin, ADMA, AGE-peptides).|Albuminuria and 24-hour blood-pressure measurements.|Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.|DNA for genotyping.|Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate). |
| Sponsor/Collaborators: | Sponsor: Steno Diabetes Center Copenhagen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 100 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2001-03 |
| Completion Date: | 2003-03 |
| Results First Posted: | |
| Last Update Posted: | 2008-12-08 |
| Locations: | Steno Diabetes Center, Gentofte, 2820, Denmark |
| URL: | https://clinicaltrials.gov/show/NCT00118950 |
