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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: vildagliptin; Drug: LAF237 placebo; Drug: Glimepiride

• Registration Number: NCT00099944
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-12-21
• Study First Submitted QC: 2004-12-21
• Study First Posted: 2004-12-22
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAF237 placebo + glimepiride 4 mg qd	LAF237 placebo	LAF237 placebo + glimepiride 4 mg qd
LAF237 50 mg qd + glimepiride 4 mg qd	vildagliptin	LAF237 50 mg qd + glimepiride 4 mg qd
LAF237 50 mg qd + glimepiride 4 mg qd	Glimepiride	LAF237 50 mg qd + glimepiride 4 mg qd
LAF237 placebo + glimepiride 4 mg qd	Glimepiride	LAF237 placebo + glimepiride 4 mg qd
LAF237 50 mg bid + glimepiride 4 mg qd	vildagliptin	LAF237 50 mg bid + glimepiride 4 mg qd
LAF237 50 mg bid + glimepiride 4 mg qd	Glimepiride	LAF237 50 mg bid + glimepiride 4 mg qd

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States