Status:
UNKNOWN
To Evaluate the Efficacy and Safety of JT-003 add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT05296044
Start Date
April 5 2022
End Date
February 28 2024
Last Update
March 25 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea