Back to resultsA Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GK Activator (2)
Ethanol
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose.
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.
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437606
Brief Title
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GK Activator (2)
Intervention Description
100mg po
Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
40g po
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Berlin
Country
Germany
City
Kiel
Country
Germany
City
Bratislava
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
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