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

This study has been terminated.
(poor recruitment)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00437606
First received: February 19, 2007
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: GK Activator (2)
Drug: Ethanol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.'

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose. [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Estimated Study Completion Date: February 2009
Arms Assigned Interventions
Experimental: 1 Drug: GK Activator (2)
100mg po
Experimental: 2 Drug: Ethanol
40g po
Experimental: 3 Drug: GK Activator (2)
100mg po
Drug: Ethanol
40g po

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437606

Locations
Germany
Berlin, Germany
Kiel, Germany
Slovakia
Bratislava, Slovakia
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00437606     History of Changes
Other Study ID Numbers: NP20131
Study First Received: February 19, 2007
Last Updated: April 16, 2008
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Liver Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014