Clinical Trials Directory

Trials / Completed

CompletedNCT01990469

Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin

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

Summary

After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Detailed description

Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.

Conditions

Interventions

TypeNameDescription
DRUGGemigliptinDPP-4 inhibitor
DRUGGemigliptin placeboPlacebo of Gemigliptin

Timeline

Start date
2014-01-01
Primary completion
2015-04-01
Completion
2015-04-01
First posted
2013-11-21
Last updated
2016-04-19

Source: ClinicalTrials.gov record NCT01990469. Inclusion in this directory is not an endorsement.