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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00237237

CLAF237A2354

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind