A comparative study to assess the effect of Vildagliptin versus Glimepiride on glucose variability in type 2 diabetic patients uncontrolled on metformin alone. - VARIABLE

ovartis Healthcare Pvt Ltd0 个研究点目标入组 324 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients who have given written informed consent to participate in the study.
•2.Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
•3.Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%).
•4.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).

•1.Age 75 years ; BMI 22 or 40 kg/m2
•2.Patients who are on Insulin therapy at the time of study entry.
•3.Type 1 Diabetes Mellitus patients.
•4.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)
•5.Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.

发起方

ovartis Healthcare Pvt Ltd