Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368368
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-08-22
Brief Title:
A Study of the Effect of Renal Impairment on the Activity of GK Activator 2 in Patients With Type 2 Diabetes
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Study to Investigate the Effect of Renal Impairment on the PharmacokineticsPharmacodynamics and Safety of GK Activator 2 Following a Single Oral Dose Administration in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the effect of renal impairment on the pharmacokineticspharmacodynamics 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None