A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-06-30

Brief Summary

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This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

100mg po

2

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

40g po

3

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

100mg po

Ethanol

Intervention Type DRUG

40g po

Interventions

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GK Activator (2)

100mg po

Intervention Type DRUG

Ethanol

40g po

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* type 2 diabetes;
* normal hepatic function, or mild or moderate hepatic impairment.

Exclusion Criteria

* type 1 diabetes, or latent autoimmune diabetes in adults;
* diabetic neuropathy, retinopathy or nephropathy;
* treatment with insulin or PPAR gamma agonist within 6 weeks of screening;
* clinically significant cardiovascular disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No