NCT04634500 (ENHANCE-M) is a Phase 3 clinical trial of Dapagliflozin in T2DM (Type 2 Diabetes Mellitus), sponsored by Daewoong Pharmaceutical Co. LTD..

Who is sponsoring NCT04634500?

NCT04634500 is sponsored by Daewoong Pharmaceutical Co. LTD..

What drugs are being tested in NCT04634500?

Interventions in NCT04634500: Dapagliflozin.

What condition does NCT04634500 study?

NCT04634500 studies T2DM (Type 2 Diabetes Mellitus).

Is NCT04634500 still recruiting?

NCT04634500 is currently completed. Last updated 25 October 2022.

Last reviewed 2022-10-25 · How we verify

NCT04634500: ENHANCE-M

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

The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

Completed Phase 3 Last updated 25 October 2022

What this trial tests

Phase 3 trial testing Dapagliflozin in T2DM (Type 2 Diabetes Mellitus) in 200 participants. Completed in 3 November 2021.

Timeline

18 November 2020

Primary endpoint
3 November 2021

3 November 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	200
Start date	18 November 2020
Primary completion	3 November 2021
Estimated completion	3 November 2021
Sites	1 location across South Korea

Drugs / interventions tested

Dapagliflozin (DAPAGLIFLOZIN) — 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

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.

Publications & conference data

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

Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial.
Han KA, Kim YH, Kim DM, Lee BW, et al · · 2023 · cited 13× · PMID 36756676 · DOI 10.4093/dmj.2022.0315
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 Dapagliflozin

Trials testing the same drug.

NCT07491042 — Impact of SGLT2 Inhibitors on Chronic Peritoneal Dialysis Patients. · NA · recruiting
NCT07351643 — CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF · Phase 4 · not yet recruiting
NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
NCT07239011 — Dapagliflozin in Depression · Phase 1, PHASE2 · recruiting
NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting

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 NCT04634500 (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: 25 October 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/NCT04634500.

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