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

Type 2 Diabetes Mellitus Clinical Trial

— VARIABLE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01910441
• Other study ID #: CLAF237AIN03
• Status: Terminated
• Phase: Phase 4
• First received: July 25, 2013
• Last updated: September 22, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India (DCGI)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin
Vildagliptin 50 mg twice daily
• Glimepiride
Glimepiride 1-6 mg once daily
• Metformin
Metformin (1000-1500 mg daily)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Amplitude of Glycemic Excursions (MAGE)		16 weeks	No