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

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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: JT-001
* Drug: JT-001 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JT-001<br>Drug: JT-001 | Drug: JT-001<br>* Subjects take the investigational products once a day for 24 weeks.<br>|
| Placebo Comparator: JT-001 Placebo<br>Drug: JT-001 Placebo | Drug: JT-001 Placebo<br>* Subjects take the investigational products once a day for 24 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c | Changes in HbA1c at the 24th week from the baseline | 24th Week |