NCT02949193

Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Detailed description

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks. 2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	evogliptin	evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg
DRUG	Sitagliptin	sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-11-01
• Completion: 2015-05-01
• First posted: 2016-10-31
• Last updated: 2016-10-31

Locations

1 site across 1 country: South Korea