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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
Glucokinase activator currently under development
Frontage Clinical Services Inc.
Hackensack, New Jersey, United States
GMR for Cmax of empagliflozin
Geometric mean ratio (GMR) between combination and empagliflozin monotherapy for Cmax of empagliflozin
Time frame: up to 10 days
GMR for AUC0-24h of empagliflozin
GMR between combination and empagliflozin in monotherapy for AUC0-24h of empagliflozin
Time frame: up to 10 days
GMR for Cmax of dorzagliatin
GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin
Time frame: up to 15 days
GMR for AUC0-24h of dorzagliatin
GMR between combination and dorzagliatin in monotherapy for AUC0-24h of dorzagliatin
Time frame: up to 15 days
Adverse events
Number of participants with AEs
Time frame: up to 15 days
Abnormal vital signs
Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature)
Time frame: up to 15 days
Abnormal clinical laboratory findings
Number of participants with abnormal clinical laboratory findings
Time frame: up to 15 days
12-lead ECG
Number of participants with abnormal ECG VR,, PR, QRS and QT
Time frame: up to 15 days
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iCmax of glucose
The incremental peak plasma concentration of glucose post OGTT
Time frame: up to 15 days
iAUC0-4h of glucose
The incremental area under the concentration-time curve of glucose in 4 hours post OGTT
Time frame: up to 15 days
iCmax of insulin
The incremental peak plasma concentration of insulin post OGTT
Time frame: up to 15 days
iAUC0-4h of insulin
The incremental area under the concentration-time curve of insulin in 4 hours post OGTT
Time frame: up to 15 days
iCmax of C-peptide
The incremental peak plasma concentration of C-peptide post OGTT
Time frame: up to 15 days
iAUC0-4h of C-peptide
The incremental area under the concentration-time curve of C-peptide in 4 hours post OGTT
Time frame: up to 15 days