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This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential arm ABC | Experimental | A: Empagliflozin 25 mg QD in the morning on Days 1-5; B: Empagliflozin 25 mg in the morning and Dorzagliatin 75 mg BID (morning and evening) on Days 6-10, with only the morning dose on Day 10; C: Dorzagliatin 75 mg BID (morning and evening) on Days 11-15, with only the morning dose on Day 15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMR for Cmax of empagliflozin | Geometric mean ratio (GMR) between combination and empagliflozin monotherapy for Cmax of empagliflozin | up to 10 days |
| GMR for AUC0-24h of empagliflozin | GMR between combination and empagliflozin in monotherapy for AUC0-24h of empagliflozin | up to 10 days |
| GMR for Cmax of dorzagliatin | GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin | up to 15 days |
| GMR for AUC0-24h of dorzagliatin | GMR between combination and dorzagliatin in monotherapy for AUC0-24h of dorzagliatin | up to 15 days |
| Adverse events | Number of participants with AEs | up to 15 days |
| Abnormal vital signs | Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) | up to 15 days |
| Abnormal clinical laboratory findings | Number of participants with abnormal clinical laboratory findings | up to 15 days |
| 12-lead ECG | Number of participants with abnormal ECG VR,, PR, QRS and QT |
| Measure | Description | Time Frame |
|---|---|---|
| iCmax of glucose | The incremental peak plasma concentration of glucose post OGTT | up to 15 days |
| iAUC0-4h of glucose | The incremental area under the concentration-time curve of glucose in 4 hours post OGTT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory J Tracey, MD | Frontage Clinical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Services Inc. | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42014686 | Derived | Liu H, Zhang Y, Feng L, Zhang J, Sun Y, Zhao Y, Jiang M, Liu X, Tracey GJ, Chen L, Liu D. A pharmacokinetic and pharmacodynamic drug-drug interaction study of dorzagliatin and empagliflozin in patients with type 2 diabetes and obesity: an open-label phase I trial. Nat Commun. 2026 Apr 21. doi: 10.1038/s41467-026-71798-x. Online ahead of print. |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| C000629807 | Dorzagliatin |
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| Dorzagliatin | Drug | Glucokinase activator currently under development |
|
|
| up to 15 days |
| up to 15 days |
| iCmax of insulin | The incremental peak plasma concentration of insulin post OGTT | up to 15 days |
| iAUC0-4h of insulin | The incremental area under the concentration-time curve of insulin in 4 hours post OGTT | up to 15 days |
| iCmax of C-peptide | The incremental peak plasma concentration of C-peptide post OGTT | up to 15 days |
| iAUC0-4h of C-peptide | The incremental area under the concentration-time curve of C-peptide in 4 hours post OGTT | up to 15 days |