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)

Type 2 DM Patients With Moderate or Severe Renal Impairment Clinical Trial

— GUARD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968044
• Other study ID #: LG-DPCL015
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2013
• Last updated: March 21, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea:Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Type 2 DM Patients With Moderate or Severe Renal Impairment

Intervention

Drug:
• Gemigliptin

• Placebo to Linagliptin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change		HbA1c change from baseline to week 12	No
Secondary	HbA1c Change		HbA1c change from baselint to week 6, 52	No
Secondary	FPG		FPG change from baseline to week 6,12,52	No
Secondary	Glycated albumin		Glycated albumin change from baseline to week 6,12,52	No
Secondary	Fructosamin		Fructosamin change from baseline to week 6,12,52	No
Secondary	Waist		Waist change from baseline to week 12,52	No
Secondary	HbA1c responser (HbA1c<7.0%)		HbA1c responser rate at week 12,52	No
Secondary	Fasting serum C-peptide		Fasting serum C-peptide change from baseline to week 12,52	No
Secondary	Fasting Lipid parameters		Fasting Lipid parameters change from baseline to week 12,52	No
Secondary	Albuminuria		Albuminuria change from baseline to week 12,52	No