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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JT-001 | Experimental | Drug: JT-001 |
|
| JT-001 Placebo | Placebo Comparator | Drug: JT-001 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JT-001 | Drug | Subjects take the investigational products once a day for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c | Changes in HbA1c at the 24th week from the baseline | 24th Week |
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Inclusion Criteria:
Exclusion Criteria:
Those who had allergic reaction to main ingredients or components of the investigational products.
Patients with the following major systemic disease
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 are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bong-Soo Cha, MD., Ph.D | Contact | +82-2-2228-1962 | BSCHA@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38310875 | Derived | 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. |
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| JT-001 Placebo |
| Drug |
Subjects take the investigational products once a day for 24 weeks. |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000722705 | GS-621763 |
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