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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LAF237 placebo; Drug: vildagliptin; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099944

CLAF237A2305

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 two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.

Enrollment: 515 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Blood glucose criteria must be met
• Previously treated with a sulfonylurea for at least 3 months
• 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 glimepiride
• 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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515 participants in 3 patient groups, including a placebo group

LAF237 50 mg qd + glimepiride 4 mg qd

Experimental group

Description:

LAF237 50 mg qd + glimepiride 4 mg qd

Treatment:

Drug: Glimepiride

Drug: vildagliptin

LAF237 50 mg bid + glimepiride 4 mg qd

Experimental group

Description:

LAF237 50 mg bid + glimepiride 4 mg qd

Treatment:

Drug: Glimepiride

Drug: vildagliptin

LAF237 placebo + glimepiride 4 mg qd

Placebo Comparator group

Description:

LAF237 placebo + glimepiride 4 mg qd

Treatment:

Drug: Glimepiride

Drug: LAF237 placebo