Clinical Trial Details
| Trial ID: | L1609 |
| Source ID: | NCT02251431 |
| Associated Drug: | Bydureon |
| Title: | Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02251431/results |
| Conditions: | Type 2 Diabetes Mellitus|Chronic Kidney Disease|Left Ventricular Diastolic Dysfunction |
| Interventions: | DRUG: BYDUREON|DRUG: Placebo |
| Outcome Measures: | Primary: Galectin-3, Mean change in plasma galectin-3 (pg/ml), 38 weeks|ST2, Mean change in plasma ST2 (pg/ml), 38 weeks|NGAL, Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio, 38 weeks|KIM-1, Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio, 38 weeks|L-FABP, Mean change in urine L-type fatty acid binding protein:Cr ratio, 38 weeks|IL-18, Mean change in urine interleukin-18:Cr ratio, 38 weeks|Alpha GST, Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio, 38 weeks|Troponin I, Mean change in plasma ultrasensitive troponin I (pg/ml), 38 weeks|Pi GST, Mean change in pi glutathione S-transferase (piGST):Cr ratio, 38 weeks|NAG, Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio, 38 weeks|Cystatin-C, Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr), 38 weeks|BNP, Mean change in plasma B-type natriuretic peptide BNP (pg/ml), 38 weeks|ACR, Mean change in urine albumin:Cr ratio (ACR), 38 weeks | |
| Sponsor/Collaborators: | Sponsor: Baylor Research Institute |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 57 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-11 |
| Completion Date: | 2019-12 |
| Results First Posted: | 2023-05-17 |
| Last Update Posted: | 2023-05-17 |
| Locations: | Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital, Dallas, Texas, 75226, United States |
| URL: | https://clinicaltrials.gov/show/NCT02251431 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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