NCT05101135UnknownPhase 3
This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-001 Combination Therapy.
Jeil Pharmaceutical Co., Ltd.1 site in 1 country256 target enrollmentStarted: November 17, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Changes in HbA1c
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
JT-001
Experimental
Drug: JT-001
Intervention: JT-001 (Drug)
JT-001 Placebo
Placebo Comparator
Drug: JT-001 Placebo
Intervention: JT-001 Placebo (Drug)
Outcomes
Primary Outcomes
Changes in HbA1c
Time Frame: 24th Week
Changes in HbA1c at the 24th week from the baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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