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

NCT00106340 Phase 3 COMPLETED

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	3118
Start date	2005-03
Completion	2008-05-20

Conditions

• Diabetes Mellitus, Type 2

Interventions

• vildagliptin
• glimepiride
• Metformin
• Vildagliptin matching placebo
• Glimepiride matching placebo

Primary outcomes

• Time to HbA1c >8% — 2 year

Countries

United States, Germany