Trials / Active Not Recruiting
Active Not RecruitingNCT05505994
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (actual)
- Sponsor
- Daewoong Pharmaceutical Co. LTD. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Detailed description
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
Conditions
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Glucose Metabolism Disorders
- Metabolic Disease
- Endocrine System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DWP16001 | DWP16001 A mg tablet |
| DRUG | Dapagliflozin | Dapagliflozin tablet |
| DRUG | DWP16001 Placebo | DWP16001 Placebo tablet |
| DRUG | Dapagliflozin Placebo | Dapagliflozin Placebo tablet |
Timeline
- Start date
- 2022-09-28
- Primary completion
- 2024-02-26
- Completion
- 2024-09-01
- First posted
- 2022-08-18
- Last updated
- 2024-04-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05505994. Inclusion in this directory is not an endorsement.