Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02061969
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2014-02-11
Brief Title:
ADA Linagliptin in Long Term Care
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Randomized Controlled Study Comparing a DPP4 Inhibitor Linagliptin and Basal Insulin Glargine in Long-Term Care Residents With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2018-07
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:
This is a study to determine whether glycemic control as measured by change in HbA1c and frequency of hypoglycemia is different between treatment with linagliptin Tradjenta and basal insulin in long term care residentsLTC with Type 2 diabetesT2D Patients with poorly controlled diabetes HbA1c 75 will be randomized to a 6-month intervention with linagliptin or glargine insulin metformin for both treatments Our hypothesis is that treatment with linagliptin a once daily DPP4-inhibitor will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D We will also determine differences in clinical outcome resource utilization and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin We will compare differences in complications infectious and non-infectious neurological and cardiovascular events emergency room visits and hospitalizations between groups during the 6 months of intervention
Detailed Description:
None
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 |
|---|---|---|---|
| IRB00071946 | OTHER | VA site IRB number | None |