- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437606
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
August 23, 2016 updated by: Hoffmann-La Roche
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.'
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
100mg po
|
Experimental: 2
|
40g po
|
Experimental: 3
|
100mg po
40g po
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Days 1, 8 and 15
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AEs, laboratory parameters.
Time Frame: Throughout study
|
Throughout study
|
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
|
Days 1, 8 and 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
February 19, 2007
First Submitted That Met QC Criteria
February 19, 2007
First Posted (Estimate)
February 21, 2007
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 23, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP20131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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