Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients (VARIABLE)
Type 2 Diabetes Mellitus

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Glycemic variability
Eligibility Criteria
Inclusion Criteria:
- Patients who have given written informed consent to participate in the study.
- Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
- Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%).
- Patients with HbA1C levels within the range > 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).
Exclusion Criteria:
- Age > 75 years ; BMI <22 or >40 kg/m2
- Patients who are on Insulin therapy at the time of study entry.
- Type 1 Diabetes Mellitus patients.
Patients with severe renal (creatinine clearance < 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST > 3 x ULN).
Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)
- Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.
Other protocol defined inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group A: Vildagliptin plus metformin
Group B: Glimepiride plus metformin
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).