Skip to main content
OpenTrials
Completed

NCT Number: NCT01968044

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)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 DM Patients With Moderate or Severe Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemigliptin

Drug

Placebo to Linagliptin

Drug

Primary outcomes

  1. HbA1c change

    Time frame: HbA1c change from baseline to week 12

Secondary outcomes

  1. HbA1c Change

    Time frame: HbA1c change from baselint to week 6, 52

  2. FPG

    Time frame: FPG change from baseline to week 6,12,52

  3. Glycated albumin

    Time frame: Glycated albumin change from baseline to week 6,12,52

  4. Fructosamin

    Time frame: Fructosamin change from baseline to week 6,12,52

  5. Waist

    Time frame: Waist change from baseline to week 12,52

  6. HbA1c responser (HbA1c<7.0%)

    Time frame: HbA1c responser rate at week 12,52

  7. Fasting serum C-peptide

    Time frame: Fasting serum C-peptide change from baseline to week 12,52

  8. Fasting Lipid parameters

    Time frame: Fasting Lipid parameters change from baseline to week 12,52

  9. Albuminuria

    Time frame: Albuminuria change from baseline to week 12,52

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

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

Acronym: GUARD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2013
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.