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 enrollmentNovember 17, 2021

ConditionsType 2 Diabetes Mellitus

InterventionsJT-001 JT-001 Placebo

DrugsJT-001 JT-001 Placebo

Overview

Phase: Phase 3
Intervention: JT-001
Conditions: Type 2 Diabetes Mellitus
Sponsor: Jeil Pharmaceutical Co., Ltd.
Enrollment: 256
Locations: 1
Primary Endpoint: Changes in HbA1c
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 17, 2021

End Date

October 31, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jeil Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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