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) (GUARD)

March 21, 2016 updated by: LG Life Sciences

A Multicenter,Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase IIIb Study to Evaluate the Safety and Efficacy After 12 Weeks Administration of Gemigliptin and Placebo in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment With an Additional 40 Weeks, Double-blind,Active-controlled, Double-dummy,Long-term Extension Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus
  • Patients with moderate or severe renal insufficiency
  • All patients give written informed consent

Exclusion Criteria:

  • Has type 1 diabetes mellitus or a history of ketoacidosis
  • Is on dialysis or is likely to need dialysis during the study
  • Has active liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemigliptin
Participant will remain gemigliptin 50mg throughout entire study (52 weeks).
Drug: Gemigliptin
Other: Placebo to linagliptin
Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.
Drug: Placebo to Linagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c change
Time Frame: HbA1c change from baseline to week 12
HbA1c change from baseline to week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c Change
Time Frame: HbA1c change from baselint to week 6, 52
HbA1c change from baselint to week 6, 52
FPG
Time Frame: FPG change from baseline to week 6,12,52
FPG change from baseline to week 6,12,52
Glycated albumin
Time Frame: Glycated albumin change from baseline to week 6,12,52
Glycated albumin change from baseline to week 6,12,52
Fructosamin
Time Frame: Fructosamin change from baseline to week 6,12,52
Fructosamin change from baseline to week 6,12,52
Waist
Time Frame: Waist change from baseline to week 12,52
Waist change from baseline to week 12,52
HbA1c responser (HbA1c<7.0%)
Time Frame: HbA1c responser rate at week 12,52
HbA1c responser rate at week 12,52
Fasting serum C-peptide
Time Frame: Fasting serum C-peptide change from baseline to week 12,52
Fasting serum C-peptide change from baseline to week 12,52
Fasting Lipid parameters
Time Frame: Fasting Lipid parameters change from baseline to week 12,52
Fasting Lipid parameters change from baseline to week 12,52
Albuminuria
Time Frame: Albuminuria change from baseline to week 12,52
Albuminuria change from baseline to week 12,52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Investigators

  • Principal Investigator: DR Cha, MD, Ph.D, Korea University Ansan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-DPCL015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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