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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2018-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Intervention Type DRUG

LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.

Interventions

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LIK066

LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No