Status:
COMPLETED
Drug Interaction Study Between Dorzagliatin and Sitagliptin
Lead Sponsor:
Hua Medicine Limited
Conditions:
Patients
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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;
- Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
- HbA1c ≥7% and ≤10.5%;
Exclusion
- Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL;
- Type 1 diabetes mellitus;
- Reported incidence of severe or serious hypoglycemia within 3 months prior to screening;
- Known contraindications to sitagliptin;
- Clinically significant gastrointestinal disorder;
- History or symptoms of clinically significant cardiovascular disease within one year prior to screening;
- 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;
- 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 sitagliptin;
- 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, hHBsAg, or hepatitis C antibody;
- Positive pregnancy test result;
- Female is breast-feeding or planning to become pregnant;
- 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 or acute loss of blood during the 90 days prior to screening;
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03790839
Start Date
January 31 2019
End Date
August 30 2019
Last Update
February 28 2023
Active Locations (1)
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1
Frontage Clinical Services Inc.
Hackensack, New Jersey, United States, 07601