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

Phase 3

Completed

• Conditions: T2DM
• Interventions: Drug: Gemigliptin placebo; Drug: Gemigliptin

• Registration Number: NCT01990469
• Lead Sponsor: LG Life Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Study Start: 2014-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

1. Patients with Type 2 Diabetes Mellitus
2. Adults aged ≥ 19 years old
3. Patients with HbA1c 7%~11% at Visit 1

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Gemigliptin placebo	Gemigliptin placebo
Gemigliptin	Gemigliptin	Gemigliptin 50mg qd

Primary Outcome Measures

Name	Time	Method
Change of HbAlc from baseline at Week 24	24 weeks