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

NCT05101135 | Unknown Phase 3 DMC

• 1 other identifier: JLP-2008-301
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c

  Changes in HbA1c at the 24th week from the baseline

  24th Week

Study Arms (2)

JT-001

EXPERIMENTAL

Drug: JT-001

Drug: JT-001

JT-001 Placebo

PLACEBO COMPARATOR

Drug: JT-001 Placebo

Drug: JT-001 Placebo

Interventions

JT-001 DRUG

Subjects take the investigational products once a day for 24 weeks.

JT-001

JT-001 Placebo DRUG

Subjects take the investigational products once a day for 24 weeks.

JT-001 Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Heo JH, Han KA, Hong JH, Seo HA, Hong EG, Yu JM, Jung HS, Cha BS. Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial. Diabetes Metab J. 2024 Sep;48(5):937-948. doi: 10.4093/dmj.2023.0314. Epub 2024 Feb 2.

  PMID: 38310875 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

GS-621763

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Bong-Soo Cha, MD., Ph.D

CONTACT

+82-2-2228-1962; BSCHA@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: November 17, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)