Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Vildagliptin 100 mg qd; Drug: Metformin 1500 mg daily

• Registration Number: NCT00383578
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-03
• Primary Completion: 2008-05
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Disposition First Posted: 2013-01-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Age from 65 years to the upper age limit recommended by local prescribing information for metformin
• Drug naive patients with type 2 diabetes.
• Body mass index (BMI) in the range of 22-40 kg/m2.
• HbA1c in the range of 7 to 9% inclusive
• FPG <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

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin 100 mg qd	-
Metformin	Metformin 1500 mg daily	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	after 24 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Investigative Centers; 🇩🇪 Nurnberg, Germany

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland