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NCT00396357 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00396357
Other study ID # CLAF237A23104
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2006

Study information
Verified date December 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 914
Est. completion date
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 78 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

• metformin

Locations
Country Name City State
Germany Novartis Investigative Site Multiple Locations
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 hemoglobin A 1 c (HbA1c) after 24 weeks of treatment 24 weeks
Secondary Adverse event profile after 24 weeks of treatment 24 weeks
Secondary Gastrointestinal tolerability after 24 weeks of treatment 24 weeks
Secondary Patients with endpoint HbA1c <7% and <6.5% after 24 weeks 24 weeks
Secondary Patients with reduction in HbA1c >0.7% after 24 weeks 24 weeks
Secondary Change from baseline in fasting plasma glucose after 24 weeks 24 weeks
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