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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)
Information provided by:
Hoffmann-La Roche Identifier:
First received: February 19, 2007
Last updated: August 23, 2016
Last verified: August 2016
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
Intervention Model: Parallel Assignment
Masking: None (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.'

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 ]

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 ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]

Enrollment: 2
Study Start Date: March 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00437606

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

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00437606     History of Changes
Other Study ID Numbers: NP20131
Study First Received: February 19, 2007
Last Updated: August 23, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 21, 2017