Drug Interaction Study Between Dorzagliatin and Sitagliptin

NCT ID: NCT03790839

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2019-08-30

Brief Summary

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.

Conditions

Patients

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequential arm ABC

A: Sitagliptin 100 mg QD in the morning on Days 1-5; B: Sitagliptin 100 mg QD 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.

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

Sitagliptin (Januvia® 100 mg tablets for oral administration)

Dorzagliatin

Intervention Type: DRUG

Glucokinase activator currently under development

Interventions

Sitagliptin

Sitagliptin (Januvia® 100 mg tablets for oral administration)

Intervention Type: DRUG

Dorzagliatin

Glucokinase activator currently under development

Intervention Type: DRUG

Other Intervention Names

Januvia; HMS5552

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;

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 or serious hypoglycemia within 3 months prior to screening;

4. Known contraindications to sitagliptin;

5. Clinically significant gastrointestinal disorder;

6. History or symptoms of clinically significant cardiovascular disease within one year prior to screening;

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;

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 sitagliptin;

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, hHBsAg, or hepatitis C antibody;

20. Positive pregnancy test result;

21. Female is breast-feeding or planning to become pregnant;

22. Treated with any investigational drugs within 6 weeks prior to screening;

23. Reported history of prescription drug abuse;

24. Reported history of alcohol abuse;

25. Reported history of donation or or acute loss of blood during the 90 days prior to screening;

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hua Medicine Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Tracey, MD

Role: PRINCIPAL_INVESTIGATOR

Frontage Clinical Services, Inc.

Locations

Frontage Clinical Services Inc.

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

HMM0111

Identifier Type: -

Identifier Source: org_study_id