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

NCT ID: NCT05296044

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2024-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JT-003

Drug: JT-003

Group Type: EXPERIMENTAL

JT-003

Intervention Type: DRUG

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

JT-003 Placebo

Drug: JT-003 Placebo

Group Type: PLACEBO_COMPARATOR

JT-003 Placebo

Intervention Type: DRUG

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

Interventions

JT-003

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

Intervention Type: DRUG

JT-003 Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults aged 19 years or older with type 2 diabetes mellitus

2. Subjects with 7.0% ≤ HbA1c ≤ 11% at baseline

3. Those with > 45 kg/m2 of BMI

4. Those who voluntarily signed the informed consent to participate in this study

Exclusion Criteria

1. Those who had allergic reaction to main ingredients or components of the investigational products.

2. 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

3. Those with a history of malignant tumor within 5 years

4. Those with history of alcohol or drug abuse within 1 years

5. Those with heart failure (NYHA class II~IV) or who had suffered from heart failure within 6 months

6. Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends

7. Those who need to take prohibited concomitant medications stated during the study period.

8. Females who are pregnant or breastfeeding or patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method

9. Those who are judged unsuitable for the study by a principal investigator or investigators

10. Those who have been administered with the following drugs or expected to require the continued administration during the study period:

• Those who have been administered with obesity drugs within 12 weeks
• Those being administered with thyroid medications and whose dose has been modified within 6 weeks
• Those administered with systemic steroid agents (Prednisolone, >30 mg/day) within 2 weeks
• Those being administered with diuretics and whose dose has been modified within 8 weeks as (however, dose reduction is accepted.)

11. Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

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

Role: CONTACT

kspark@snu.ac.kr

+82-2-2072-1673

Facility Contacts

Kyung-Soo Park, MD., Ph.D

Role: primary

References

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.

Reference Type: DERIVED

PMID: 41151541 (View on PubMed)

Other Identifiers

JLP-2008-302

Identifier Type: -

Identifier Source: org_study_id