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)

Phase 3

Completed

• Conditions: Type 2 DM Patients With Moderate or Severe Renal Impairment
• Interventions: Drug: Gemigliptin; Drug: Placebo to Linagliptin

• Registration Number: NCT01968044
• Lead Sponsor: LG Life Sciences

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c change	HbA1c change from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
HbA1c Change	HbA1c change from baselint to week 6, 52
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 responser (HbA1c<7.0%)	HbA1c responser rate at week 12,52
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