Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286429
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2006-02-01
Brief Title:
Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes
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 Insulin 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 determine the efficacy and safety of alogliptin once daily QD taken in combination with insulin for the treatment of Type 2 Diabetes
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 alogliptin SYR-322 for 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 efficacy of alogliptin in combination with insulin in subjects who are inadequately controlled on insulin alone with or without metformin 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 alogliptin SYR-322 for 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 efficacy of alogliptin in combination with insulin in subjects who are inadequately controlled on insulin alone with or without metformin 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 |
|---|---|---|---|
| 2005-004671-38 | EUDRACT_NUMBER | None | None |
| U1111-1113-8369 | REGISTRY | WHO | None |