Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00396357

Collaborator

(none)

914

Enrollment

Locations

Arms

457

Patients Per Site

Study Details

Study Description

Brief Summary

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: metformin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

914 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vildagliptin + metformin	Drug: Vildagliptin
Active Comparator: Metformin	Drug: metformin

Arm

Intervention/Treatment

Experimental: vildagliptin + metformin

Drug: Vildagliptin

Active Comparator: Metformin

Drug: metformin

Outcome Measures

Primary Outcome Measures

Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment [24 weeks]

Secondary Outcome Measures

Adverse event profile after 24 weeks of treatment [24 weeks]
Gastrointestinal tolerability after 24 weeks of treatment [24 weeks]
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks [24 weeks]
Patients with reduction in HbA1c >0.7% after 24 weeks [24 weeks]
Change from baseline in fasting plasma glucose after 24 weeks [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-78 years inclusive
Type 2 diabetes diagnosis at least 2 months prior to study entry
Body mass index in the range of 22-45 kg/m2
HbA1c in the range of 6.5 to 9% inclusive
Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion Criteria:

A history of type 1 diabetes
Evidence of significant diabetic complications
Treatment with insulin or any other oral antidiabetic agents
Congestive heart failure requiring pharmacologic treatment
Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply