A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride Alone

LG Life Sciences1 site in 1 country230 target enrollmentJune 2014

ConditionsType 2 Diabetes Mellitus

InterventionsGemigliptin/Glimepiride combination

DrugsGemigliptin/Glimepiride combination

Overview

Phase: Phase 3
Intervention: Gemigliptin/Glimepiride combination
Conditions: Type 2 Diabetes Mellitus
Sponsor: LG Life Sciences
Enrollment: 230
Locations: 1
Primary Endpoint: HbA1c Changes
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

September 2016

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LG Life Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with type 2 diabetes
•Adults who are at least 19 years old
•Patients who have taken Glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before Visit 1 (screening) as monotherapy or Patients who have taken Glimepiride at a stable dose (≥4mg/day) and Metformin for 8 weeks or more before Visit 1 (screening) as combination therapy
•Patients who satisfy the following HbA1c (%) criteria: 7 ≤ HbA1c ≤ 11
•Patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
•Patients who fall under one of the following 3 cases
•Patients who are surgically sterile
•Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
•Fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.

Exclusion Criteria

•Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
•Patients with gestational diabetes or secondary diabetes
•Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
•Patients with thyroid gland dysfunction and TSH that is out of normal range
•Patients with pituitary insufficiency or adrenal insufficiency
•Patients with hereditary problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
•Female patients who are pregnant or breastfeeding
•Patients whose BMI exceeds 40 kg/m2
•Patients whose creatinine clearance is below 30mL/min/1.73m2
•Patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose ALT/AST level exceeds 2.5 times the upper limit of the normal range

Arms & Interventions

Gemigliptin/Glimepiride combination

Gemigliptin 50mg qd added to ongoing Glimepiride as fix-dose combination. The subjects will take a total of 2 tablets, Gemigliptin/Glimepiride combination \& Placebo for Glimepiride.

Intervention: Gemigliptin/Glimepiride combination