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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014