Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377442
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-09-15
Brief Title:
A Drug-Drug Interaction Study of GK Activator 2 and Simvastatin in Patients With Type 2 Diabetes
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Crossover Study to Investigate the Potential Interaction Between GK Activator 2 and Simvastatin 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 assess the potential pharmacokinetic interaction between GK Activator 2 and simvastatin and the potential effect of simvastatin on the glucose-lowering effect of GK Activator 2 in patients with type 2 diabetes Patients will be randomized to one of 6 treatment sequences to receive single doses of aGK Activator 2 100mg po bsimvastatin 80mg po and cGK Activator 2 100mg simvastatin 80mg po Dosing will take place on study days 1 8 and 15 and there will be a 7-14 day follow-up period after the last 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