Clinical Trial Details
| Trial ID: | L4941 |
| Source ID: | NCT04654390 |
| Associated Drug: | Dwp16001 Amg |
| Title: | The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | T2DM (Type 2 Diabetes Mellitus) |
| Interventions: | DRUG: DWP16001 Amg |
| Outcome Measures: | Primary: Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP, HbA1c level at Week 24 after administration of the IP, at Week 24 | Secondary: Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP, HbA1c level at Weeks 6, 12, and 18 after administration of the IP, at weeks 6, 12, and 18|Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP, FPG level at Weeks 6, 12, 18, and 24 after administration of the IP, at weeks 6, 12, 18, and 24|Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP, HbA1c level \< 7% at Weeks 6, 12, 18, and 24 after administration of the IP, at weeks 6, 12, 18, and 24 |
| Sponsor/Collaborators: | Sponsor: Daewoong Pharmaceutical Co. LTD. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 270 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2020-12-30 |
| Completion Date: | 2021-12-17 |
| Results First Posted: | |
| Last Update Posted: | 2022-04-01 |
| Locations: | The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea, Bucheon, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT04654390 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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