NCT02946541

A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

Detailed description

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks. 2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	evogliptin 5mg	evogliptin 5mg, QD
DRUG	Placebo	Placebo, QD

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2015-04-01
• First posted: 2016-10-27
• Last updated: 2017-03-28

Locations

1 site across 1 country: South Korea