Study to compare effect of Vildagliptin vs. Glimepiride on glucose variation in patients not controlled on metformin alone.

Phase 4

• Conditions: Health Condition 1: null- Tyape II Diabetes Mellitus

• Registration Number: CTRI/2013/12/004244
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 324

Inclusion Criteria

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).

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified