Drug Interaction Study Between Dorzagliatin and Sitagliptin

Completed · Phase 1

Conditions studied: Patients

In brief

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.

Key facts

Study ID

NCT03790839

Run by

Hua Medicine Limited

People needed

15

Starts

2019-01-31

Expected to finish

2019-08-30

Last updated by the study team

2023-02-28

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%;

You may not qualify if…

• 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;

Where it is running

• Frontage Clinical Services Inc. — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.