Vildagliptin Compared to Glimepiride 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; Drug: Glimepiride matching placebo; Drug: Vildagliptin matching placebo; Drug: Metformin; Drug: glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106340

CLAF237A2308

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 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.

Enrollment: 3,118 patients

Sex: All

Ages: 18 to 73 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,118 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: Glimepiride matching placebo

Drug: vildagliptin

Drug: Metformin

Glimepiride

Active Comparator group

Treatment:

Drug: glimepiride

Drug: Vildagliptin matching placebo

Drug: Metformin