Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00382096

Collaborator

(none)

1,179

Enrollment

Locations

Arms

21.1

Duration (Months)

589.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes

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

Study Design

Study Type:

Interventional

Actual Enrollment :

1179 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Jun 3, 2008

Actual Study Completion Date :

Jun 3, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin + Metformin Dose 1	Drug: Vildagliptin + Metformin
Experimental: Vildagliptin + Metformin Dose 2	Drug: Vildagliptin + Metformin
Active Comparator: Vildagliptin	Drug: Vildagliptin
Active Comparator: Metformin	Drug: Metformin

Outcome Measures

Primary Outcome Measures

Change from baseline in HbA1c [At week 24]

Secondary Outcome Measures

Change from baseline in fasting plasma glucose [At week 24]
Percent of patients with endpoint HbA1c <7% [At week 24]
Percent of patients with reduction in HbA1c >/=0.7% [At week 24]
Adverse event profile after treatment [At week 24]
Change from baseline in body weight [At week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
Diagnosis of T2DM for at least 4 weeks prior to study entry
Age 18 - 78 years inclusive
Body mass index (BMI) of 22 - 40 kg/m2
HbA1c: 7.5 - 11% inclusive
FPG <270 mg/dL (15 mmol/L)