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)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Type 2 DM Patients With Moderate or Severe Renal Impairment

Intervention / Treatment
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* Drug: Gemigliptin
* Drug: Placebo to Linagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemigliptin<br>Participant will remain gemigliptin 50mg throughout entire study (52 weeks). | Drug: Gemigliptin<br> <br> |
| Other: Placebo to linagliptin<br>Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52. | Drug: Placebo to Linagliptin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change |  | HbA1c change from baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal impairment