Drug Interaction Study Between Dorzagliatin and Empagliflozin
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequential arm ABC 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. |
Drug: Empagliflozin
Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
Other Names:
Drug: Dorzagliatin
Glucokinase activator currently under development
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax,ss [up to 5 days]
maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
- AUCτ,ss [up to 5 days]
area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects diagnosed with T2DM within at least 3 months prior to screening
-
Male and/or female subjects between the ages of 30 and 65 years, inclusive;
-
Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive, at screening;
-
Fasting C-peptide test result >0.3 nmol/L (>0.90 ng/mL);
-
HbA1c ≥7% and ≤10.5%;
Exclusion Criteria:
-
Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;
-
Type 1 diabetes mellitus;
-
Reported incidence of severe hypoglycemia within 3 months prior to screening;
-
Known contraindications to empagliflozin;
-
Clinically significant gastrointestinal disorder;
-
History or symptoms of clinically significant cardiovascular disease;
-
History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
-
Reported history of clinically significant central nervous system disease including within one year prior to screening;
-
Reported history of liver disease;
-
Reported history of clinically significant renal disease;
-
Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
-
Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
-
Known or suspected malignancy;
-
Any reported hypersensitivity or intolerance to empagliflozin;
-
Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
-
Systolic blood pressure <90 or >160 mmHg or diastolic blood pressure <60 or >100 mmHg at screening;
-
A hospital admission or major surgery within 90 days prior to screening;
-
Uncontrolled hypertriglyceridemia >500 mg/dL;
-
Positive blood screen for HIV, HBsAg, or hepatitis C antibody;
-
Positive pregnancy test result;
-
Treated with any investigational drugs within 6 weeks prior to screening;
-
Reported history of prescription drug abuse;
-
Reported history of alcohol abuse
-
Reported history of donation or acute loss of blood during the 90 days prior to screening;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Frontage Clinical Services Inc. | Hackensack | New Jersey | United States | 07601 |
Sponsors and Collaborators
- Hua Medicine Limited
Investigators
- Principal Investigator: Gregory J Tracey, MD, Frontage Clinical Services, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMM0112