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

Novartis

Status and phase: Completed; Phase 2

Conditions: Renal Impairment

Treatments: Drug: LIK066

Study type: Interventional

Funder types: Industry

Identifiers

NCT03131479

2016-004770-18 (EudraCT Number)

CLIK066B2202

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 5 patient groups

Mild

Experimental group

Description:

Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.

Treatment:

Drug: LIK066

Moderate A

Experimental group

Description:

Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.

Treatment:

Drug: LIK066

Moderate B

Experimental group

Description:

Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.

Treatment:

Drug: LIK066

Severe

Experimental group

Description:

Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.

Treatment:

Drug: LIK066

Normal

Experimental group

Description:

Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.

Treatment:

Drug: LIK066