NCT02831361

Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study)

A Multinational, Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Gemigliptin 50 mg q.d Compared With Placebo Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or on insulin in combination with metformin stably for 8 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Gemigliptin
DRUG	Gemigliptin placebo
DRUG	Metformin	For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study
PROCEDURE	Diet/exercise questionnaire	doing exercise with about intermediate intensity(50\~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regualr diet without greater changes in life style as much as possible during the whole study period. the questionnaire regarding diet/exercise will be collected at -week2, week 1 week 7, week 13, week 19, week 25

Timeline

• Start date: 2016-10-17
• Primary completion: 2018-02-08
• Completion: 2018-02-08
• First posted: 2016-07-13
• Last updated: 2018-02-22