Back to resultsA 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)
Primary Purpose
Type 2 DM Patients With Moderate or Severe Renal Impairment
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemigliptin
Placebo to Linagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 DM Patients With Moderate or Severe Renal Impairment focused on measuring renal impairment
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gemigliptin
Placebo to linagliptin
Arm Description
Participant will remain gemigliptin 50mg throughout entire study (52 weeks).
Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.
Outcomes
Primary Outcome Measures
HbA1c change
Secondary Outcome Measures
HbA1c Change
FPG
Glycated albumin
Fructosamin
Waist
HbA1c responser (HbA1c<7.0%)
Fasting serum C-peptide
Fasting Lipid parameters
Albuminuria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01968044
Brief Title
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)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 DM Patients With Moderate or Severe Renal Impairment
Keywords
renal impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemigliptin
Arm Type
Experimental
Arm Description
Participant will remain gemigliptin 50mg throughout entire study (52 weeks).
Arm Title
Placebo to linagliptin
Arm Type
Other
Arm Description
Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Intervention Type
Drug
Intervention Name(s)
Placebo to Linagliptin
Primary Outcome Measure Information:
Title
HbA1c change
Time Frame
HbA1c change from baseline to week 12
Secondary Outcome Measure Information:
Title
HbA1c Change
Time Frame
HbA1c change from baselint to week 6, 52
Title
FPG
Time Frame
FPG change from baseline to week 6,12,52
Title
Glycated albumin
Time Frame
Glycated albumin change from baseline to week 6,12,52
Title
Fructosamin
Time Frame
Fructosamin change from baseline to week 6,12,52
Title
Waist
Time Frame
Waist change from baseline to week 12,52
Title
HbA1c responser (HbA1c<7.0%)
Time Frame
HbA1c responser rate at week 12,52
Title
Fasting serum C-peptide
Time Frame
Fasting serum C-peptide change from baseline to week 12,52
Title
Fasting Lipid parameters
Time Frame
Fasting Lipid parameters change from baseline to week 12,52
Title
Albuminuria
Time Frame
Albuminuria change from baseline to week 12,52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DR Cha, MD, Ph.D
Organizational Affiliation
Korea University Ansan Hospital
Official's Role
Principal Investigator
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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)
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