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NCT00382096 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00382096
Other study ID # CLMF237A2302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2006
Est. completion date June 3, 2008

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1179
Est. completion date June 3, 2008
Est. primary completion date June 3, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 78 Years
Eligibility 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) Exclusion Criteria - Pregnant or lactating female - A history of type 1 diabetes - Evidence of significant diabetic complications - Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

• Metformin

• Vildagliptin + Metformin

Locations
Country Name City State
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c At week 24
Secondary Change from baseline in fasting plasma glucose At week 24
Secondary Percent of patients with endpoint HbA1c <7% At week 24
Secondary Percent of patients with reduction in HbA1c >/=0.7% At week 24
Secondary Adverse event profile after treatment At week 24
Secondary Change from baseline in body weight At week 24
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