Drug Interaction Study Between Dorzagliatin and Empagliflozin

Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790787
• Other study ID #: HMM0112
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: December 2018
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Patients

Intervention

Drug:
• Empagliflozin
Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
• Dorzagliatin
Glucokinase activator currently under development

Locations

Country	Name	City	State
United States	Frontage Clinical Services Inc.	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hua Medicine Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss	maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t	up to 5 days
Primary	AUCt,ss	area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t	up to 5 days