At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes with HbA1c <10% at screening
- ✓Age 18-78 years inclusive
- ✓BMI ≤50 kg/m²
- ✓Controlled health condition per medical history, physical exam, ECG, and labs at screening
- ✕Type 1 diabetes
- ✕Significant liver dysfunction: ALT, AST, gamma-GT, alkaline phosphatase >3× ULN or bilirubin >1.5× ULN
- ✕On dialysis
- ✕Clinically significant GI disorder affecting drug or glucose absorption (malabsorption)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Parallel-group Study to Assess the Effect of LIK066 on Urinary Glucose Excretion, Pharmacokinetics, Safety and Tolerability Following Multiple Dose Administration in Patients With Decreased Renal Function Compared to Subjects With Normal Renal Function
In Brief
A Phase 2 clinical trial evaluating LIK066 for Renal Impairment. Completed, enrolled 53 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.