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

This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: JT-003; Drug: JT-003 Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 245
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kyung-Soo Park, M.D. Ph.D; Phone Number: +82-2-2072-1673; Email: kspark@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Kyung-Soo Park, MD., Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JT-003; Drug: JT-003	Drug: JT-003; Subjects take the investigational products once a day for 24 weeks.
PLACEBO_COMPARATOR: JT-003 Placebo; Drug: JT-003 Placebo	Drug: JT-003 Placebo; Subjects take the investigational products once a day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HbA1c	Changes in HbA1c at the 24 week from the baseline	24 week from the baseline

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 5, 2022
• Primary Completion (ANTICIPATED): October 31, 2023
• Study Completion (ANTICIPATED): February 28, 2024

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (ACTUAL): March 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: JLP-2008-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No