Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: vildagliptin (Drug)

Phase: Phase 3

Status: Completed

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. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official title: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

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

Primary outcome:

Safety of vildagliptin in combination with glimepiride during 52 weeks of treatment

Change from baseline in HbA1c at 52 weeks

Secondary outcome:

Change in HbA1c between 24 weeks and 52 weeks

Change from baseline in fasting plasma glucose at 52 weeks

Change in fasting plasma glucose between 24 weeks and 52 weeks

Change from baseline in HOMA B at 52 weeks

Change from baseline in HOMA IR at 52 weeks

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Only patients successfully completing study CLAF237A2305 are eligible

- Written informed consent

- Ability to comply with all study requirements

Exclusion Criteria:

- Premature discontinuation from study CLAF237A2305

- Other protocol-defined exclusion criteria may apply

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

Starting date: November 2004
Last updated: June 1, 2006