Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388518
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-10-16
Brief Title:
A Study of Aleglitazar in Patients With Type 2 Diabetes
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus
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 6 arm study will assess the efficacy safety tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes Patients will be randomised to one of 6 treatment arms to receive one of 4 doses of aleglitazar Actos as an open-label active comparator or placebo Aleglitazar will be administered starting from a dose of 005mg po daily and Actos will be administered at a dose of 45mg once daily The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 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