10 unknown, 7 completed, 1 not yet recruiting. 12 Phase 1, 5 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 12 | Unknown 8, Completed 4 |
| Phase 3 | 5 | Completed 3, Not yet recruiting 1, Unknown 1 |
| Phase 2 | 1 | Unknown 1 |
Follow DWP16001: new trials by email Literature Review of DWP16001 trials Research Report on DWP16001
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus DWP16001, DWC202518, Placebo of DWP16001 - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Not yet recruiting | Daewoong Pharmaceutical Co. LTD. | 510 | 2026-06-01 | 2026-06-02 |
| Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults DWP16001, DWC202511, DWC202512 - Healthy | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 18 | 2025-11-09 | 2026-02-11 |
| To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function DWP16001 - Diabetes Mellitus, Type 2 | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 24 | 2023-04-13 | 2024-04-08 |
| To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers DWP16001 - Healthy | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 32 | 2023-03-09 | 2023-04-04 |
| To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination DWC202213, DWJ1563, DWP16001 - FDC, Diabetes Mellitus, Type 2 | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 40 | 2023-01-25 | 2023-02-21 |
| The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin DWP16001, Dapagliflozin, DWP16001 Placebo - Diabetes Mellitus, Diabetes Mellitus, Type 2 | Phase 3 | Unknown | Daewoong Pharmaceutical Co. LTD. | 340 | 2022-09-28 | 2024-04-04 |
| Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults DWP16001, DWC202204+DWC202205, DWP16001+DWC202204+DWC202205 - Healthy | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 53 | 2022-08-26 | 2022-08-15 |
| A Crossover Study of DWJ1525 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers DWJ1525, DWP16001, DWC202101 - Healthy | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 37 | 2022-04-15 | 2022-07-11 |
| Study to Evaluate the Safety and PK Properties of DWP16001 in Healthy Subjects With Various Ethnicities DWP16001 - Healthy | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 24 | 2022-02-14 | 2022-01-26 |
| The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults DWP16001, DWP202010 - Healthy Volunteers | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 24 | 2021-12-10 | 2022-04-11 |
| Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin DWP16001 - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 159 | 2021-05-25 | 2022-10-25 |
| The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes. Dapagliflozin - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 200 | 2020-11-18 | 2022-10-25 |
| The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus. DWP16001 - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 140 | 2020-11-11 | 2022-10-25 |
| Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults DWP16001, DWC202001+DWC202002, DWP16001+DWC202001+DWC202002 - Healthy | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 34 | 2020-04-01 | 2020-04-27 |
| Type 2 Diabetes Patients With Renal Impairment DWP16001 - Type2 Diabetes | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 35 | 2020-01-01 | 2020-01-09 |
| Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study) DWP16001, Metformin IR, DWP16001+Metformin IR - Healthy | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 34 | 2019-08-14 | 2020-01-13 |
| Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus DWP16001, Placebo - T2DM (Type 2 Diabetes Mellitus) | Phase 2 | Unknown | Daewoong Pharmaceutical Co. LTD. | 196 | 2019-07-10 | 2019-07-18 |
| Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers DWP16001, Placebo, Dapagliflozin - Healthy | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 123 | 2017-12-03 | 2019-08-21 |
Diabetes Mellitus, Type 2 (8) · Diabetes Mellitus (1) · Endocrine System Diseases (1) · Glucose Metabolism Disorders (1) · Metabolic Diseases (1)
Daewoong Pharmaceutical Co. LTD. (18)
South Korea (14) · China (1)
Linong Ji, Dr. (1)
PMID 38456558, PMID 36756676, PMID 37593838, PMID 38618974, PMID 39054871