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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)

NCT02831361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2018-02-22

No results posted yet for this study

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

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 & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-17
Primary Completion
2018-02-08
Completion
2018-02-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831361 on ClinicalTrials.gov