Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518115
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2007-08-17
Brief Title:
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A 16-Week Parallel-Group Double-Blind Randomized Placebo-Controlled Multicenter Dose-Ranging Study to Evaluate the Efficacy Safety and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155 With Byetta as an Open Label Active Reference in Subjects 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 study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only This study will investigate the safety tolerability and efficacy of Albiglutide GSK716155 and will measure the levels of Albiglutide GSK716155 in the bloodstream when it is given for 16 weeks As a comparison some subjects will receive exenatide instead of Albiglutide GSK716155 The study will involve weekly visits for 17 weeksand less frequent follow-up visits for an additional 10 weeks Assessments include repeat blood sampling and monitoring of any side effects
Detailed Description:
A 16-week parallel-group double-blind randomized placebo-controlled multicenter dose-ranging study to evaluate the efficacy safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide GSK716155 with Byetta as an open-label active reference in subjects with Type 2 Diabetes Mellitus
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