Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517465
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-08-16
Brief Title:
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multi-center Double-blind Randomized Placebo-controlled Parallel-group Multiple-ascending-dose Study to Investigate the Pharmacokinetics Pharmacodynamics Safety and Tolerability of R1511 in Type 2 Diabetic T2D Patients
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 4 arm study will evaluate the pharmacokinetics pharmacodynamics safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus The starting dose of R1511 will be 100mg po bid for 5 12 days this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 12 days after a satisfactory assessment of blinded safety tolerability pharmacokinetic and pharmacodynamic data of the previous 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