Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: vildagliptin; Drug: thiazolidinedione (TZD)

• Registration Number: NCT00396227
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-02
• Study First Posted: 2006-11-06
• Primary Completion: 2007-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2665

Inclusion Criteria

• Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
• Agreement to maintain the same dose of metformin from screening to the end of the study
• Age in the range of 18-80 years
• Body mass index (BMI) in the range of 22-40 kg/m2
• HbA1c in the range of 7.0 to 10%
• FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria

• A history of type 1 diabetes
• Liver disease
• Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vildagliptin	Vildagliptin 100mg + Met
TZD	thiazolidinedione (TZD)	TZD + metformin

Primary Outcome Measures

Name	Time	Method
Change from baseline in HemoglobinA1c (HbA1c)	after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body weight	after 12 weeks of treatment
Change from baseline in fasting plasma glucose (FPG)	after 12 weeks of treatment
Incidence of prespecified adverse events while on treatment with study drug	12 week treatment duration

Trial Locations

Locations (1)

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