Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121641
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2005-07-15
Brief Title:
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of this clinical research study is to learn whether saxagliptin BMS-477118 is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
Detailed Description:
All subjects will participate in a lead-in period and qualifying subjects will continue into a short-term randomized treatment period Subjects who complete the short-term period will be eligible to enter the long term extension period Also subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication Subjects with screening hemoglobin A1c A1C 100 and 120 who otherwise meet all inclusionexclusion criteria were eligible to enroll directly into Open-Label Treatment Cohort Direct Enrollees and receive open-label saxagliptin 10 mg Those who completed the short-term period were eligible to enter into the long-term treatment extension periodSaxagliptin dose titration was not permitted
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