Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients

Study Overview
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Brief Summary
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Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

Official Title
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A Comparative Study to Assess the Effect of Vildagliptin Versus Glimepiride on Glucose Variability in Type 2 Diabetic Patients Uncontrolled on Metformin Alone

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Glimepiride
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Vildagliptin plus metformin<br>Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). | Drug: Vildagliptin<br>* Vildagliptin 50 mg twice daily<br>Drug: Metformin<br>* Metformin (1000-1500 mg daily)<br>|
| Active Comparator: Group B: Glimepiride plus metformin<br>Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily). | Drug: Glimepiride<br>* Glimepiride 1-6 mg once daily<br>Drug: Metformin<br>* Metformin (1000-1500 mg daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Amplitude of Glycemic Excursions (MAGE) |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Glycemic variability