Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286468
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2006-02-01
Brief Title:
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 SYR-322 When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2012-02
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 study is to evaluate the efficacy and safety of alogliptin once daily QD combined with a sulfonylurea in adults with type 2 diabetes mellitus
Detailed Description:
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus of which 90 to 95 are type 2 The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age obesity family history history of gestational diabetes and physical inactivity Over the next decade a marked increase in the number of adults with diabetes mellitus is expected
Takeda is developing SYR-322 alogliptin for the improvement of glycemic control in patients with type 2 diabetes mellitus Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic glucose control in patients with type 2 diabetes
The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center Study participation is anticipated to be about 34 weeks or 85 months
Takeda is developing SYR-322 alogliptin for the improvement of glycemic control in patients with type 2 diabetes mellitus Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic glucose control in patients with type 2 diabetes
The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center Study participation is anticipated to be about 34 weeks or 85 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-004667-36 | EUDRACT_NUMBER | None | None |
| U1111-1113-8506 | REGISTRY | WHO | None |