Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: vildagliptin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

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

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Official title: Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

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

Primary outcome: Time to HbA1c >8%

Secondary outcome:

Change from baseline in HbA1c at 5 years

Adverse event profile after 5 years of treatment

Coefficient of failure for HbA1c from week 24 to 5 years

Change from baseline in fasting plasma glucose at 5 years

Change from baseline in body weight at 5 years

Minimum age: 18 Years. Maximum age: 73 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- On a stable dose of metformin as defined by the protocol

- Body mass index (BMI) in the range 22-45

- Blood glucose criteria must be met

Exclusion Criteria:

- Pregnancy or lactation

- Type 1 diabetes

- Evidence of significant diabetic complications

- Evidence of serious cardiovascular complications

- Laboratory value abnormalities as defined by the protocol

- Other protocol-defined exclusion criteria may apply

Investigative Centers, Nurnberg, Germany

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: March 2005
Last updated: August 17, 2007