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

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Vildagliptin; Drug: Glimepiride; Drug: Metformin

• Registration Number: NCT01910441
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-09
• Results First Submitted: 2015-09-22
• Results First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Results First Posted: 2015-10-28
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Glimepiride plus metformin	Metformin	Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).
Group A: Vildagliptin plus metformin	Metformin	Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
Group A: Vildagliptin plus metformin	Vildagliptin	Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
Group B: Glimepiride plus metformin	Glimepiride	Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).

Primary Outcome Measures

Name	Time	Method
Mean Amplitude of Glycemic Excursions (MAGE)	16 weeks