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

NCT01990469 Phase 3 COMPLETED

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.

Details

Lead sponsor	LG Life Sciences
Phase	Phase 3
Status	COMPLETED
Enrolment	219
Start date	2014-01
Completion	2015-04

Conditions

• T2DM

Interventions

• Gemigliptin
• Gemigliptin placebo

Primary outcomes

• Change of HbAlc from baseline at Week 24 — 24 weeks