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

Roche

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Ethanol; Drug: GK Activator (2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437606

NP20131

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: GK Activator (2)

2

Experimental group

Treatment:

Drug: Ethanol

3

Experimental group

Treatment:

Drug: Ethanol

Drug: GK Activator (2)