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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 pioglitazone 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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Metformin; Pioglitazone; Vildagliptin

Criteria

Inclusion Criteria:

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

• Blood glucose criteria must be met

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

Exclusion Criteria:

• History of type 1 diabetes

• Pregnancy or lactation

• Evidence of significant diabetic complications

• Serious cardiovascular events within the past 6 months

• Laboratory value abnormalities as defined by the protocol

• Known sensitivity to pioglitazone

• Other protocol-defined exclusion criteria may apply