To Evaluate the Efficacy and Safety of JT-003 add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

NCT05296044 | Unknown Phase 3 DMC

• 1 other identifier: JLP-2008-302
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of JT-003 Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c

  Changes in HbA1c at the 24 week from the baseline

  24 week from the baseline

Study Arms (2)

JT-003

EXPERIMENTAL

Drug: JT-003

Drug: JT-003

JT-003 Placebo

PLACEBO COMPARATOR

Drug: JT-003 Placebo

Drug: JT-003 Placebo

Interventions

JT-003 DRUG

Subjects take the investigational products once a day for 24 weeks.

JT-003

JT-003 Placebo DRUG

Subjects take the investigational products once a day for 24 weeks.

JT-003 Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older with type 2 diabetes mellitus
• Subjects with 7.0% ≤ HbA1c ≤ 11% at baseline
• Those with \> 45 kg/m2 of BMI
• Those who voluntarily signed the informed consent to participate in this study

You may not qualify if:

• Those who had allergic reaction to main ingredients or components of the investigational products.
• Patients with the following major systemic disease
• Patients with type 1 diabetes mellitus, secondary diabetes, or congenital renal diabetes etc.)
• Patients with pituitary insufficiency or adrenal dysfunction
• Patients with uncontrolled glycosemia(FPG \> 270 mg/dL)
• Patients with uncontrolled hypertension(SBP \> 180 mmHg or DBP \> 110 mmHg
• Patients with severe hypertriglyceridemia (Triglyceride \> 500 mg/dL)
• Patients with severe renal dysfunction
• Patients with liver dysfunction
• Patients with AIDS
• Those with clinically significant severe infection or trauma based on an investigator's judgement
• Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia
• Unstable mental illness not regulated by drugs
• Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
• Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Hong JH, Han KA, Hwang YC, Hong EG, Kim HJ, Lee CB, Cho HC, Won JC, Kim HS, Kim EH, Koh G, Ahn KH, Park KS. Efficacy and Safety of High-Dose Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial. Diabetes Metab J. 2025 Oct 28. doi: 10.4093/dmj.2024.0696. Online ahead of print.

  PMID: 41151541 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Kyung-Soo Park, M.D. Ph.D

CONTACT

+82-2-2072-1673; kspark@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: April 5, 2022
• Primary Completion: October 31, 2023
• Study Completion: February 28, 2024
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

KR (1)