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

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ClinicalTrials.gov Identifier: NCT00437606
Recruitment Status : Terminated (poor recruitment)
First Posted : February 21, 2007
Last Update Posted : August 24, 2016
Sponsor:
Information provided by:
Hoffmann-La Roche

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
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.'
Study Start Date : March 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. AEs, laboratory parameters. [ Time Frame: Throughout study ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437606


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

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00437606     History of Changes
Other Study ID Numbers: NP20131
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs