Clinical Trial Details
| Trial ID: | L2885 |
| Source ID: | NCT01968044 |
| Associated Drug: | Gemigliptin |
| 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 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 DM Patients With Moderate or Severe Renal Impairment |
| Interventions: | DRUG: Gemigliptin|DRUG: Placebo to Linagliptin |
| Outcome Measures: | Primary: HbA1c change, HbA1c change from baseline to week 12 | Secondary: 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 |
| Sponsor/Collaborators: | Sponsor: LG Life Sciences |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 132 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-10 |
| Completion Date: | 2015-10 |
| Results First Posted: | |
| Last Update Posted: | 2016-03-23 |
| Locations: | Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01968044 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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