Clinical Trial Details
| Trial ID: | L1867 |
| Source ID: | NCT03717194 |
| Associated Drug: | Ertugliflozin |
| Title: | Effect of Ertugliflozin on Cardiac Function in Diabetes |
| Acronym: | ERTU-GLS |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03717194/results |
| Conditions: | Type2 Diabetes|Heart Failure |
| Interventions: | DRUG: Ertugliflozin|DRUG: Placebo |
| Outcome Measures: | Primary: Left Ventricular Global Longitudinal Strain (LVGLS), Change in LVGLS after 24 weeks of treatment, Baseline, Week 24 | Secondary: Left Ventricular Mass Index (LVMI), Change in LVMI after 24 weeks of treatment, Baseline, Week 24|Left Ventricular Ejection Fraction (LVEF), Change in LVEF after 24 weeks of treatment, Baseline, Week 24|E/e' Ratio, Change in E/e' ratio after 24 weeks of treatment, Baseline, Week 24|Left Atrium Ventricular Index (LAVI), Change in LVVI after 24 weeks of treatment, Baseline, Week 24|Left Ventricular End-diastolic Volume (LVEDV), Change in LVEDV after 24 weeks of treatment, Baseline, Week 24 | Other: N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP), Baseline, Week 24|Troponin-T, Baseline, Week 24|Angiotensin-converting Enzyme 2 (ACE2), Baseline, Week 24|Angiotensin (1-7), Baseline, Week 24 |
| Sponsor/Collaborators: | Sponsor: Soo Lim | Collaborators: MSD Korea Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 102 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2019-06-01 |
| Completion Date: | 2023-04-30 |
| Results First Posted: | 2024-11-20 |
| Last Update Posted: | 2024-11-20 |
| Locations: | Seoul National University Bundang Hospita;, Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT03717194 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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