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

NCT ID: NCT01990469

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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T2DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gemigliptin

Gemigliptin 50mg qd

Group Type EXPERIMENTAL

Gemigliptin

Intervention Type DRUG

DPP-4 inhibitor

Placebo

Gemigliptin placebo

Group Type PLACEBO_COMPARATOR

Gemigliptin placebo

Intervention Type DRUG

Placebo of Gemigliptin

Interventions

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Gemigliptin

DPP-4 inhibitor

Intervention Type DRUG

Gemigliptin placebo

Placebo of Gemigliptin

Intervention Type DRUG

Other Intervention Names

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Zemiglo

Eligibility Criteria

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Inclusion Criteria

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

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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LG-DPCL010

Identifier Type: -

Identifier Source: org_study_id

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