A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.
1 other identifier
interventional
5
2 countries
5
Brief Summary
This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Jan 2006
Longer than P75 for phase_1 diabetes-mellitus-type-2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 22, 2006
CompletedFirst Posted
Study publicly available on registry
August 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedNovember 2, 2016
November 1, 2016
1.6 years
August 22, 2006
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Vital signs, adverse events, laboratory parameters.
Throughout study
Secondary Outcomes (1)
AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. Glucose Cmax and Cmin, and percentage decrease in glucose from baseline.
Throughout study.
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for \>=1 week prior to dosing with GK Activator (2);
- normal renal function, or moderate or severe impairment.
You may not qualify if:
- type 1 diabetes;
- treatment with insulin or PPAR gamma agonist within 6 months of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Cypress, California, 90630, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Dallas, Texas, 75247, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Bratislava, 833 01, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2006
First Posted
August 24, 2006
Study Start
January 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11