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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Vildagliptin (Drug); Metformin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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

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 design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in HbA1c after 24 weeks

Secondary outcome:

Change from baseline in fasting plasma glucose after 24 weeks

Percent of patients with endpoint HbA1c <7% after 24 weeks

Percent of patients with reduction in HbA1c >/=0.7% after 24 weeks

Adverse event profile after 24 weeks of treatment

Change from baseline in body weight after 24 weeks

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

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

Investigative Centers, Germany; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Novartis Pharmaceuticals, Phone: 862-778-8300

Novartis patient recruitment website

Starting date: September 2006
Last updated: January 17, 2007