Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-29 @ 10:02 PM
Study NCT ID:
NCT01183104
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2010-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
START-J: SiTAgliptin in eldeRly Trial in Japan
Sponsor:
Japan Association for Diabetes Education and Care
Organization:
Study Overview
Official Title:
Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-03
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:
START-J
Brief Summary:
The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UMIN000004047 | OTHER | UMIN | View |