Status:
TERMINATED
Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01910441
Start Date
July 1 2013
End Date
September 1 2014
Last Update
October 28 2015
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