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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemigliptin | Experimental | Participant will remain gemigliptin 50mg throughout entire study (52 weeks). |
|
| Placebo to linagliptin | Other | Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemigliptin | Drug |
| ||
| Placebo to Linagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change | HbA1c change from baseline to week 12 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DR Cha, MD, Ph.D | Korea University Ansan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
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| 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 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
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