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)

PHASE3CompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

October 17, 2016

Primary Completion Date

February 8, 2018

Study Completion Date

February 8, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
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"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LG Life Sciences

INDUSTRY

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) | Biotech Hunter | Biotech Hunter