NCT00494884

Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	vildagliptin

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-07-02
• Last updated: 2017-02-27

Locations

1 site across 1 country: Germany