NCT05101135 is a Phase 3 clinical trial of JT-001 in Type 2 Diabetes Mellitus, sponsored by Jeil Pharmaceutical Co., Ltd..

Who is sponsoring NCT05101135?

NCT05101135 is sponsored by Jeil Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05101135?

Interventions in NCT05101135: JT-001, JT-001 Placebo.

What condition does NCT05101135 study?

NCT05101135 studies Type 2 Diabetes Mellitus.

Is NCT05101135 still recruiting?

NCT05101135 is currently status unknown. Last updated 7 March 2022.

Last reviewed 2022-03-07 · How we verify

NCT05101135

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

To Evaluate the Efficacy and Safety of JT-001 add-on in Paatients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

Status unknown Phase 3 Last updated 7 March 2022

What this trial tests

Phase 3 trial testing JT-001 in Type 2 Diabetes Mellitus in 256 participants. Status unknown.

Timeline

17 November 2021

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Jeil Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	256
Start date	17 November 2021
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across South Korea

Drugs / interventions tested

JT-001 — full drug profile →
JT-001 Placebo — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Jeil Pharmaceutical Co., Ltd. — full company profile →

Who can join

19 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of JT-001 Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin.

Publications & conference data

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

Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial.
Heo JH, Han KA, Hong JH, Seo HA, et al · · 2024 · cited 12× · PMID 38310875 · DOI 10.4093/dmj.2023.0314
Lipid metabolism in homeostasis and disease.
Li Z, Deng W, Yang L, Tang C, et al · · 2026 · cited 2× · PMID 41692800 · DOI 10.1038/s41392-025-02357-x
Pioglitazone as Add-On to Metformin and Dapagliflozin Yields Significant Enhancements in Glycemic Control in Poorly Controlled Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.
Sabbagh S, Hegazy A, Adel A, Ali A, et al · · 2025 · PMID 41122558 · DOI 10.7759/cureus.92794

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Jeil Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07115706 — JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive GERD · not yet recruiting
NCT06952855 — Observationa Study is a Prospective and Multi-institutional Observational Study. · completed
NCT06431399 — To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 · Phase 1 · recruiting
NCT06169059 — To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004 · Phase 1 · completed
NCT06165965 — To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008 · 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 NCT05101135 (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 Jeil Pharmaceutical Co., Ltd.
Last refreshed: 7 March 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/NCT05101135.

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