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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-001 Combination Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101135
• Other study ID #: JLP-2008-301
• Status: Recruiting
• Phase: Phase 3
• Start date: November 17, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2022
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: Bong-Soo Cha, MD., Ph.D
• Phone: +82-2-2228-1962
• Email: BSCHA[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• JT-001
Subjects take the investigational products once a day for 24 weeks.
• JT-001 Placebo
Subjects take the investigational products once a day for 24 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c	Changes in HbA1c at the 24th week from the baseline	24th Week