Clinical trial NCT03790787: Drug Interaction Study Between Dorzagliatin and Empagliflozin
Official title: A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Empagliflozin in Subjects with Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients
Lead sponsor: Hua Medicine Limited
Sponsor class: INDUSTRY
First posted: 2019-01-02
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed with T2DM within at least 3 months prior to screening
2. Male and/or female subjects between the ages of 30 and 65 years, inclusive;
3. Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive, at screening;
4. Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
5. HbA1c ≥7% and ≤10.5%;

Exclusion Criteria:

1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;
2. Type 1 diabetes mellitus;
3. Reported incidence of severe hypoglycemia within 3 months prior to screening;
4. Known contraindications to empagliflozin;
5. Clinically significant gastrointestinal disorder;
6. History or symptoms of clinically significant cardiovascular disease;
7. History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
8. Reported history of clinically significant central nervous system disease including within one year prior to screening;
9. Reported history of liver disease;
10. Reported history of clinically significant renal disease;
11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
13. Known or suspected malignancy;
14. Any reported hypersensitivity or intolerance to empagliflozin;
15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
16. Systolic blood pressure \<90 or \>160 mmHg or diastolic blood pressure \<60 or \>100 mmHg at screening;
17. A hospital admission or major surgery within 90 days prior to screening;
18. Uncontrolled hypertriglyceridemia \>500 mg/dL;
19. Positive blood screen for HIV, HBsAg, or hepatitis C antibody;
20. Positive pregnancy test result;
21. Treated with any investigational drugs within 6 weeks prior to screening;
22. Reported history of prescription drug abuse;
23. Reported history of alcohol abuse
24. Reported history of donation or acute loss of blood during the 90 days prior to screening;

Primary outcomes:
measure: GMR for Cmax of empagliflozin
timeFrame: up to 10 days
measure: GMR for AUC0-24h of empagliflozin
timeFrame: up to 10 days
measure: GMR for Cmax of dorzagliatin
timeFrame: up to 15 days
measure: GMR for AUC0-24h of dorzagliatin
timeFrame: up to 15 days
measure: Adverse events
timeFrame: up to 15 days
measure: Abnormal vital signs
timeFrame: up to 15 days
measure: Abnormal clinical laboratory findings
timeFrame: up to 15 days
measure: 12-lead ECG
timeFrame: up to 15 days
Secondary outcomes:
measure: iCmax of glucose
timeFrame: up to 15 days
measure: iAUC0-4h of glucose
timeFrame: up to 15 days
measure: iCmax of insulin
timeFrame: up to 15 days
measure: iAUC0-4h of insulin
timeFrame: up to 15 days
measure: iCmax of C-peptide
timeFrame: up to 15 days
measure: iAUC0-4h of C-peptide
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Frontage Clinical Services Inc.
state: New Jersey
Study officials:
affiliation: Frontage Clinical Services, Inc.
name: Gregory J Tracey, MD
role: PRINCIPAL_INVESTIGATOR
References: