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

Last updated: March 16, 2022
Sponsor: Jeil Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT05296044
JLP-2008-302
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Those who had allergic reaction to main ingredients or components of theinvestigational products.
  2. Patients with the following major systemic disease
  • Patients with type 1 diabetes mellitus, secondary diabetes, or congenital renaldiabetes 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 aninvestigator'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 hadunderwent surgery;
  • Those who had genetic disorders such as galactose intolerance, Lapp lactosedeficiency, or glucose-galactose malabsorption
  1. Those with a history of malignant tumor within 5 years
  2. Those with history of alcohol or drug abuse within 1 years
  3. Those with heart failure (NYHA class II~IV) or who had suffered from heart failurewithin 6 months
  4. Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1or who are scheduled to receive such surgery within 4 weeks after the study ends
  5. Those who need to take prohibited concomitant medications stated during the studyperiod.
  6. Females who are pregnant or breastfeeding or patients planning to become pregnant orof childbearing potential, but not using any recognized contraceptive method
  7. Those who are judged unsuitable for the study by a principal investigator orinvestigators
  8. Those who have been administered with the following drugs or expected to require thecontinued 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 beenmodified 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 8weeks as (however, dose reduction is accepted.)
  1. Those who are currently participating in other ongoing clinical studies or those whohave taken the investigational products from other clinical studies within 12 weeks

Study Design

Total Participants: 245
Study Start date:
April 05, 2022
Estimated Completion Date:
February 28, 2024

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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