Clinical Trial Details
| Trial ID: | L3726 |
| Source ID: | NCT03499704 |
| Associated Drug: | Pioglitazone + Alogliptin |
| Title: | A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy |
| Acronym: | EPIDOTE |
| Status: | ACTIVE_NOT_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Pioglitazone + Alogliptin|DRUG: Alogliptin|DRUG: Metformin|DRUG: Dapagliflozin |
| Outcome Measures: | Primary: Mean Change from Baseline in HbA1c at Week 26, Baseline and Week 26 | Secondary: Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 26, HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR equal to (=) fasting insulin (micro unit per milliliter \[mcU/mL\])\*fasting glucose (millimole per milliliter \[mmol/mL\])/22.5. A higher number indicates a greater insulin resistance., Baseline and Week 26|Mean Change from Baseline in Serum Lipids at Week 26, The change from baseline in serum lipids (Total Cholesterol \[TC\], Low-density Lipoprotein Cholesterol \[LDL-C\], High-density Lipoprotein Cholesterol \[HDL-C\], Triglycerides \[TGs\]) will be analyzed using mixed model repeated measures (MMRM) model., Baseline and Week 26|Number of Participants who Achieved an HbA1c Goal Target of Less than (<) 6.5 Percent (%) at Week 26, Week 26 |
| Sponsor/Collaborators: | Sponsor: Celltrion Pharm, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 133 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2020-02-11 |
| Completion Date: | 2024-06-30 |
| Results First Posted: | |
| Last Update Posted: | 2023-08-30 |
| Locations: | The Catholic University of Korea, Bucheon, St. Marys Hospital, Bucheon-si, Gyeonggi-do, 14647, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of|The Catholic University of Korea, ST. Vincents Hospital, Suwon-si, Gyeonggi-do, 16247, Korea, Republic of|Ajou University Hospital, Suwon, Gyeonggi-do, 16499, Korea, Republic of|Inje University Haeundae Paik Hospital, Busan, 48108, Korea, Republic of|Pusan National University Hospital, Busan, 49241, Korea, Republic of|YeungNam University Hospital, Daegu, 42415, Korea, Republic of|Daejeon Eulji Medical Center, Eulji University, Daejeon, 35233, Korea, Republic of|Chosun University Hospital, Gwangju, 61453, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, 03181, Korea, Republic of|Yonsei University Health System Severance Hospital, Seoul, 03722, Korea, Republic of|Kyung Hee University Hospital at Gangdong, Seoul, 05278, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Ulsan University Hospital, Ulsan, 44033, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT03499704 |
