NCT00975065

Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

A 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

Detailed description

* The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability. * Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP. * Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary. * Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)	vildagliptin 50 mg bid plus metformin 1500mg
DRUG	metformin 1500mg plus metformin 500mg or 1000mg (Diabex)	metformin 1500mg plus metformin 500mg or 1000mg

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2009-09-11
• Last updated: 2012-08-23

Locations

1 site across 1 country: South Korea