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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Vildagliptin plus metformin

Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin 50 mg twice daily

Metformin

Intervention Type DRUG

Metformin (1000-1500 mg daily)

Group B: Glimepiride plus metformin

Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Glimepiride 1-6 mg once daily

Metformin

Intervention Type DRUG

Metformin (1000-1500 mg daily)

Interventions

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Vildagliptin

Vildagliptin 50 mg twice daily

Intervention Type DRUG

Glimepiride

Glimepiride 1-6 mg once daily

Intervention Type DRUG

Metformin

Metformin (1000-1500 mg daily)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No