Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Vildagliptin; Drug: metformin

• Registration Number: NCT00396357
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-06
• Primary Completion: 2008-06
• Status Verified: 2012-12
• Disposition First Submitted: 2012-12-28
• Disposition First Submitted QC: 2012-12-28
• Disposition First Posted: 2013-01-01
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 914

Inclusion Criteria

• 18-78 years inclusive
• Type 2 diabetes diagnosis at least 2 months prior to study entry
• Body mass index in the range of 22-45 kg/m2
• HbA1c in the range of 6.5 to 9% inclusive
• Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion Criteria

• A history of type 1 diabetes
• Evidence of significant diabetic complications
• Treatment with insulin or any other oral antidiabetic agents
• Congestive heart failure requiring pharmacologic treatment
• Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vildagliptin + metformin	Vildagliptin	-
Metformin	metformin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment	24 weeks

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal tolerability after 24 weeks of treatment	24 weeks
Change from baseline in fasting plasma glucose after 24 weeks	24 weeks
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks	24 weeks
Patients with reduction in HbA1c >0.7% after 24 weeks	24 weeks
Adverse event profile after 24 weeks of treatment	24 weeks

Trial Locations

Locations (2)

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

Novartis Investigative Site; 🇩🇪 Multiple Locations, Germany