NCT04654390 is a Phase 3 clinical trial of DWP16001 Amg in T2DM (Type 2 Diabetes Mellitus), sponsored by Daewoong Pharmaceutical Co. LTD..

Who is sponsoring NCT04654390?

NCT04654390 is sponsored by Daewoong Pharmaceutical Co. LTD..

What drugs are being tested in NCT04654390?

Interventions in NCT04654390: DWP16001 Amg.

What condition does NCT04654390 study?

NCT04654390 studies T2DM (Type 2 Diabetes Mellitus).

Is NCT04654390 still recruiting?

NCT04654390 is currently completed. Last updated 1 April 2022.

Last reviewed 2022-04-01 · How we verify

NCT04654390

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus

Completed Phase 3 Last updated 1 April 2022

What this trial tests

Phase 3 trial testing DWP16001 Amg in T2DM (Type 2 Diabetes Mellitus) in 270 participants. Completed in 17 December 2021.

Timeline

30 December 2020

Primary endpoint
17 December 2021

17 December 2021

Quick facts

Lead sponsor	Daewoong Pharmaceutical Co. LTD.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	270
Start date	30 December 2020
Primary completion	17 December 2021
Estimated completion	17 December 2021
Sites	1 location across South Korea

Drugs / interventions tested

DWP16001 Amg — full drug profile →

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 19 to 80, any sex, with T2DM (Type 2 Diabetes Mellitus). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to active drug in the treatment of type 2 diabetes mellitus.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacokinetics and Tissue Distribution of Enavogliflozin in Mice and Rats.
Pang M, Jeon SY, Choi MK, Jeon JH, et al · · 2022 · cited 12× · PMID 35745783 · DOI 10.3390/pharmaceutics14061210
Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials.
Lyu YS, Hong S, Lee SE, Cho BY, et al · · 2024 · cited 4× · PMID 38360626 · DOI 10.1186/s12933-024-02155-9

Verify or expand the search:

Other trials of DWP16001 Amg

Trials testing the same drug.

NCT05376930 — Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM. · Phase 3 · completed

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04654390 (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: 1 April 2022

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/NCT04654390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing