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)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01968044

Acronym

GUARD

Enrollment

132

Registered

2013-10-23

Start date

2013-10-31

Completion date

2015-10-31

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 DM Patients With Moderate or Severe Renal Impairment

Keywords

renal impairment

Brief 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).

Interventions

DRUGGemigliptin

DRUGPlacebo to Linagliptin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c change	HbA1c change from baseline to week 12

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026