Clinical Trial Details
| Trial ID: | L2975 |
| Source ID: | NCT04632862 |
| Associated Drug: | Dwp16001 |
| Title: | The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | T2DM (Type 2 Diabetes Mellitus) |
| Interventions: | DRUG: DWP16001 |
| Outcome Measures: | Primary: HbA1c level at Week 24 after administration of the IP, 1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP, at Week 24 | Secondary: HbA1c level at Weeks 6, 12, and 18 after administration of the IP, 1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP, at weeks 6, 12, and 18|FPG level at Weeks 6, 12, 18, and 24 after administration of the IP, 2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP, at weeks 6, 12, 18, and 24|HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP, 3.Proportions of subjects who achieved 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: | 140 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2020-11-11 |
| Completion Date: | 2021-11-25 |
| Results First Posted: | |
| Last Update Posted: | 2022-10-25 |
| Locations: | Daewoong pharmatceutical, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT04632862 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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