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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JT-003
JT-003 Placebo
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JT-003

JT-003 Placebo

Arm Description

Drug: JT-003

Drug: JT-003 Placebo

Outcomes

Primary Outcome Measures

Changes in HbA1c
Changes in HbA1c at the 24 week from the baseline

Secondary Outcome Measures

Full Information

First Posted
March 16, 2022
Last Updated
March 16, 2022
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05296044
Brief Title
To Evaluate the Efficacy and Safety of JT-003 add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Official Title
This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JT-003
Arm Type
Experimental
Arm Description
Drug: JT-003
Arm Title
JT-003 Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: JT-003 Placebo
Intervention Type
Drug
Intervention Name(s)
JT-003
Intervention Description
Subjects take the investigational products once a day for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
JT-003 Placebo
Intervention Description
Subjects take the investigational products once a day for 24 weeks.
Primary Outcome Measure Information:
Title
Changes in HbA1c
Description
Changes in HbA1c at the 24 week from the baseline
Time Frame
24 week from the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Those with a history of malignant tumor within 5 years Those with history of alcohol or drug abuse within 1 years Those with heart failure (NYHA class II~IV) or who had suffered from heart failure within 6 months 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 Those who need to take prohibited concomitant medications stated during the study period. Females who are pregnant or breastfeeding or patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method Those who are judged unsuitable for the study by a principal investigator or investigators 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.) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung-Soo Park, M.D. Ph.D
Phone
+82-2-2072-1673
Email
kspark@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-Soo Park, MD., Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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