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COMPLETEDPHASE2

Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

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

NCT03131479•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 78 years

Sex

ALL

Healthy Volunteers

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 \<10% at screening.
•Body mass index (BMI) ≤ 50 kg/m\^2 at screening.

Exclusion Criteria

•Patients with Type 1 diabetes
•Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase \>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.

Locations (1)

Novartis Investigative Site

Orlando, Florida, United States

Key Dates

Start Date

April 28, 2017

Primary Completion Date

January 16, 2018

Completion Date

January 16, 2018

Last Updated

January 5, 2021

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

LIK066

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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