Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306384
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2006-03-21
Brief Title:
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Long-Term Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 SYR-322 in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2013-02
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 long-term safety of alogliptin once daily QD following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus
Detailed Description:
SYR-322 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 namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic glucose control in patients with type 2 diabetes mellitus by prolonging the beneficial effects of glucagon-like peptide-1
The rising incidence of type 2 diabetes mellitus and the limitations of the currently available treatments suggest the need for new therapies for glycemic control Studies have been undertaken in humans that evaluated the effects of directly augmenting glucagon-like peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity of dipeptidyl peptidase IV
This study is an extension of 7 controlled phase 3 studies of alogliptin These phase 3 studies included 1 monotherapy study of alogliptin SYR-322-PLC-010 NCT00286455 4 placebo-controlled add-on studies of alogliptin namely in combination with a sulfonylurea SYR-322-SULF-007 NCT00286468 metformin SYR-322-MET-008 NCT00286442 a thiazolidinedione pioglitazone SYR-322-TZD-009 NCT00286494 and insulin SYR-322-INS-011 NCT00286429 1 coadministration study with pioglitazone in combination with metformin 01-05-TL-322OPI-001 NCT00328627 and 1 coadministration study with pioglitazone 01-06-TL-322OPI-002 NCT00395512
The end of treatment or early withdrawal visit from the preceding study will be the screening visit for this study after which enrolled patients will be required to commit to approximately 22 additional visits at the study center
The rising incidence of type 2 diabetes mellitus and the limitations of the currently available treatments suggest the need for new therapies for glycemic control Studies have been undertaken in humans that evaluated the effects of directly augmenting glucagon-like peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity of dipeptidyl peptidase IV
This study is an extension of 7 controlled phase 3 studies of alogliptin These phase 3 studies included 1 monotherapy study of alogliptin SYR-322-PLC-010 NCT00286455 4 placebo-controlled add-on studies of alogliptin namely in combination with a sulfonylurea SYR-322-SULF-007 NCT00286468 metformin SYR-322-MET-008 NCT00286442 a thiazolidinedione pioglitazone SYR-322-TZD-009 NCT00286494 and insulin SYR-322-INS-011 NCT00286429 1 coadministration study with pioglitazone in combination with metformin 01-05-TL-322OPI-001 NCT00328627 and 1 coadministration study with pioglitazone 01-06-TL-322OPI-002 NCT00395512
The end of treatment or early withdrawal visit from the preceding study will be the screening visit for this study after which enrolled patients will be required to commit to approximately 22 additional visits at the study center
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 |
|---|---|---|---|
| U1111-1113-8455 | REGISTRY | WHO | None |
| 2005-004672-20 | EUDRACT_NUMBER | None | None |