Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: pioglitazone; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099853

CLAF237A2304

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 safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.

Enrollment: 362 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Blood glucose criteria must be met
• Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
• Body mass index (BMI) in the range 22-45

Exclusion criteria

• Type 1 diabetes
• Pregnancy or lactation
• Evidence of serious cardiovascular complications
• Evidence of serious diabetic complications
• 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: Quadruple Blind

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362 participants in 3 patient groups, including a placebo group

Vildagliptin 50 mg qd + pioglitazone 45 mg qd

Experimental group

Description:

Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks

Treatment:

Drug: Vildagliptin

Drug: pioglitazone

Vildagliptin 50 mg bid + pioglitazone 45 mg qd

Experimental group

Description:

Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks

Treatment:

Drug: Vildagliptin

Drug: pioglitazone

Vildagliptin placebo + pioglitazone 45 mg qd

Placebo Comparator group

Description:

Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks

Treatment:

Drug: Placebo

Drug: pioglitazone