A Clinical Trial to Study the Effects of Two Drugs, Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
This study is a multicentre, randomized, open label on comparison of pancreatic beta cell
recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for
96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in
Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus
Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin
secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes
will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in
terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction
in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in
insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching
the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population
and General safety in terms of occurrence of adverse events
Phase:
Phase 4
Details
Lead Sponsor:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals