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/AClinical Study ID
NCT05296044
JLP-2008-302
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Those who had allergic reaction to main ingredients or components of theinvestigational products.
- 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
- 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 failurewithin 6 months
- 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
- Those who need to take prohibited concomitant medications stated during the studyperiod.
- Females who are pregnant or breastfeeding or patients planning to become pregnant orof childbearing potential, but not using any recognized contraceptive method
- Those who are judged unsuitable for the study by a principal investigator orinvestigators
- 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.)
- 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 ofActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.