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Phase III Trial to Evaluate the Efficacy and Safety of Initial Combination Therapy With Gemigliptin 50mg q.d and Metformin q.d

NCT01787396 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2015-04-03

No results posted yet for this study

Summary

The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.

Conditions

Interventions

DRUG

Gemigliptin 50mg

DRUG

Placebo(Metformin)

DRUG

Metformin

DRUG

Placebo(Gemigliptin)

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01787396 on ClinicalTrials.gov