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

Novartis

Status and phase: Terminated; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Vildagliptin; Drug: Metformin; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01910441

CLAF237AIN03

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Group A: Vildagliptin plus metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Vildagliptin

Group B: Glimepiride plus metformin

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: Glimepiride