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

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: T2DM

Treatments: Drug: Gemigliptin placebo; Drug: Gemigliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01990469

LG-DPCL010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 2 patient groups, including a placebo group

Gemigliptin

Experimental group

Description:

Gemigliptin 50mg qd

Treatment:

Drug: Gemigliptin

Placebo

Placebo Comparator group

Description:

Gemigliptin placebo

Treatment:

Drug: Gemigliptin placebo