Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460941
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-04-16
Brief Title:
A Titration Study of a Glucagon-Like Peptide-1 GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Double-blind Placebo-controlled Titration Study to Investigate the Tolerability Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
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 tolerability efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin Patients will be randomized to receive either subcutaneous placebo or subcutaneous GLP-1 analogue at a dose of 20mg or a starting dose of 20mg escalating to either 30mg or 40mg weekly All patients will continue on their existing metformin treatment regimen throughout the study The anticipated time on study treatment is 3 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