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

A Nonrandomized, Open Label Study to Examine the Effect of Hepatic Impairment on the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.'

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437606

Enrollment

Registered

2007-02-21

Start date

2007-03-31

Completion date

2007-06-30

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGGK Activator (2)

100mg po

DRUGEthanol

40g po

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose.	Days 1, 8 and 15

Secondary

Measure	Time frame
tmax, AUC0-6, AUC0-last, t1/2, CL/F, Ac, CL for GK Activator (2) and M4. Cmin, Cmax, tmax and tmin of plasma glucose.	Days 1, 8 and 15
AEs, laboratory parameters.	Throughout study

Countries

Germany, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026