Phase 2
Completed N=53
Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
Source: ClinicalTrials.gov NCT03131479 ↗Enrolled (actual)
53
Serious AEs
3.8%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7 — 40.45; 31.87; 36.27; 19.88 gram (g) — p=0.154
Summary
The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7 |
40.45; 31.87; 36.27; 19.88; 5.50 | 0.154 |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for LIK066 |
565; 590; 492; 569; 650; 650 | — |
| PRIMARY Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066 |
1.00; 1.00; 1.00; 1.00; 1.00; 1.00 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066 |
2830; 3330; 3120; 3360; 4150; 3440 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7 |
4190; 5280; 5440; 6410; 9620 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1 |
310; 3610; 3440; 3520; 4450 | — |
| PRIMARY Terminal Elimination Half-life (T1/2) for LIK066 on Day 7 |
22.9; 21.8; 21.1; 20.9; 22.8 | — |
| PRIMARY Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1 |
17.4; 14.3; 14.9; 15.4; 12.4 | — |
| PRIMARY Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1 |
160; 140; 164; 176; 134 | — |
| PRIMARY Renal Clearance From Plasma (CLr) for LIK066 |
0.389; 0.348; 0.259; 0.173; 0.0522; 0.474 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
- patients with Type 2 diabetes, HbA1c 3 X ULN; serum bilirubin > 1.5 X ULN.
- Patients undergoing any method of dialysis
- clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
- subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Data sourced from ClinicalTrials.gov (NCT03131479). 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.