Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01316341 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Measured Concentration (Cmax) |
436; 1090 | — |
| PRIMARY Time to Maximum Measured Concentration (Tmax) |
1.13; 1.50 | — |
| PRIMARY Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing |
2560; 7250 | — |
| PRIMARY Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
2510; 7070 | — |
| PRIMARY Terminal Rate Constant (λz) |
0.0749; 0.0664 | — |
| PRIMARY Terminal Half-life (t1/2) |
9.25; 10.4 | — |
| PRIMARY Mean Residence Time (MRTpo) |
9.29; 10.2 | — |
| PRIMARY Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F) |
144; 127 | — |
| PRIMARY Apparent Volume of Distribution During the Terminal Phase λz (Vz/F) |
115; 115 | — |
| PRIMARY Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24) |
4030; 9940 | — |
| PRIMARY Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24). |
18.2; 17.9 | — |
| PRIMARY Renal Clearance After Extravascular Administration (CL R,0-48) |
28.9; 25.6 | — |
| PRIMARY Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss) |
489; 1250 | — |
| PRIMARY Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss) |
1.17; 1.37 | — |
| PRIMARY Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss) |
2650; 7520 | — |
| PRIMARY Terminal Rate Constant in Plasma at Steady State (λz,ss) |
0.0559; 0.0588 | — |
| PRIMARY Terminal Half-life in Plasma at Steady State (t1/2,ss) |
12.4; 11.8 | — |
| PRIMARY Mean Residence Time at Steady State (MRTpo,ss) |
10.5; 10.2 | — |
| PRIMARY Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss) |
139; 123 | — |
| PRIMARY Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss) |
150; 125 | — |
| PRIMARY Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss) |
4420; 11600 | — |
| PRIMARY Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss) |
19.9; 20.9 | — |
| PRIMARY Renal Clearance at Steady State (CL R,ss) |
27.8; 26.1 | — |
| PRIMARY Accumulation Ratio Based on AUC (R A,AUC) |
1.14; 1.17 | — |
| PRIMARY Accumulation Ratio Based on Cmax (R A,Cmax) |
1.12; 1.15 | — |
| PRIMARY Predose Plasma Concentration Before Planned Dose x (Cpre,x) |
24.64; 70.54; 25.70; 80.27; 25.24; 78.96 | — |
| PRIMARY Urinary Glucose Excretion (UGE) Change From Baseline |
-988.38; 87680.85; 82791.86; -4106.10; 95765.72; 82633.88 | — |
| PRIMARY Fasting Plasma Glucose (FPG) Change From Baseline |
-3.67; -25.56; -31.44 | — |
| SECONDARY Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference |
0; 1; 0 | — |
Eligibility Criteria
Inclusion criteria
- Chinese male and female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidinediones with at least one agent taken at 50% of its maximum dose or less, unchanged for at least 12 weeks before randomization
- Glycosylated haemoglobin A1(HbA1c) =7.0% at screening, age>=21 and age =19 and 240 mg/dl (>13.3 mmol/L) after an overnight fast at screening visit
- Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
4 Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) 5 Renal insufficiency (calculated creatinine clearance 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA 7 Neurological disorders (such as epilepsy) or psychiatric disorders 8 Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections) 9 Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 10. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 11. A marked baseline prolongation of QT/QTc interval (e.g., ECG demonstration of a QTc interval >450 ms ) at screening visit
Data sourced from ClinicalTrials.gov (NCT01316341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.