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

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.

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Key information

Conditions

T2DM Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

gemigliptin

Drug

DPP-4 inhibitor

Other names: Zemiglo

Gemigliptin Placebo

Drug

Placebo of Gemigliptin

Primary outcomes

Change of HbAlc from baseline at Week 24

Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 21, 2013
Registry last updated: Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed