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A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)

NCT01968044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2016-03-23

No results posted yet for this study

Summary

Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).

Conditions

  • Type 2 DM Patients With Moderate or Severe Renal Impairment

Interventions

DRUG

Gemigliptin

DRUG

Placebo to Linagliptin

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Principal Investigators

  • DR Cha, MD, Ph.D · Korea University Ansan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • South Korea

Study Locations

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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 NCT01968044 on ClinicalTrials.gov