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NCT04014023
A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Phase 2 trial testing DWP16001 in T2DM (Type 2 Diabetes Mellitus) in 196 participants. Status unknown.
1 March 2020
Quick facts
| Lead sponsor | Daewoong Pharmaceutical Co. LTD. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 196 |
| Start date | 10 July 2019 |
| Primary completion | 1 March 2020 |
| Estimated completion | 1 June 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- DWP16001 — full drug profile →
- Placebo
Conditions studied
- T2DM (Type 2 Diabetes Mellitus) — all drugs for T2DM (Type 2 Diabetes Mellitus) →
Sponsor
Daewoong Pharmaceutical Co. LTD. — full company profile →
Who can join
Adults 20 to 80, any sex, with T2DM (Type 2 Diabetes Mellitus). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from baseline in HbA1c
Time frame: at 12 weeks
Sponsor's own description
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparative Pharmacokinetics and Pharmacodynamics of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, DWP16001, with Dapagliflozin and Ipragliflozin.
Choi MK, Nam SJ, Ji HY, Park MJ, et al · · 2020 · cited 34× · PMID 32183468 · DOI 10.3390/pharmaceutics12030268 -
In Vitro Metabolism of DWP16001, a Novel Sodium-Glucose Cotransporter 2 Inhibitor, in Human and Animal Hepatocytes.
Kim JH, Kim DK, Choi WG, Ji HY, et al · · 2020 · cited 27× · PMID 32932946 · DOI 10.3390/pharmaceutics12090865 -
Effect of the sodium-glucose cotransporter-2 inhibitor, DWP16001, as an add-on therapy to insulin for diabetic dogs: A pilot study.
An JH, Choi HS, Choi JS, Lim HW, et al · · 2024 · cited 4× · PMID 38686463 · DOI 10.1002/vms3.1454 -
Evaluation of safety and anti-obesity effects of DWP16001 in naturally obese dogs.
Rhee B, Mahbubur RM, Jin C, Choi JS, et al · · 2022 · cited 2× · PMID 35733159 · DOI 10.1186/s12917-022-03324-2
Verify or expand the search:
- PubMed search for NCT04014023
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DWP16001
Trials testing the same drug.
- NCT07213310 — Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults · Phase 1 · completed
- NCT05747664 — To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function · Phase 1 · recruiting
- NCT05797922 — To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers · Phase 1 · unknown
- NCT05737771 — To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination · Phase 1 · unknown
- NCT05500898 — Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults · Phase 1 · unknown
Other recruiting trials for T2DM (Type 2 Diabetes Mellitus)
Currently open trials in the same condition.
- NCT07314684 — GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM · Phase 4 · recruiting
- NCT07005362 — Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D · recruiting
- NCT07244003 — Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control · Phase 4 · recruiting
- NCT07172997 — Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers · active not recruiting
- NCT06094491 — Virtual Diabetes Group Visits Across Health Systems · Phase 2 · active not recruiting
Other Daewoong Pharmaceutical Co. LTD. trials
Trials by the same sponsor.
- NCT07515560 — Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study · not yet recruiting
- NCT07516977 — Noseguard for Prevention of Respiratory Infections in Real-World Use · NA · not yet recruiting
- NCT07539415 — A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Hea · Phase 1 · not yet recruiting
- NCT07267221 — Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers · Phase 1 · recruiting
- NCT07256600 — PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04014023 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daewoong Pharmaceutical Co. LTD.
- Last refreshed: 16 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04014023.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing