Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 11:19 AM
Study NCT ID:
NCT01649466
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2012-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized Open-label Study to Compare Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Patients With Type 2 Diabetes Mellitus That do Not Reach Adequate Glycemic Control on Their Current Sulfonylurea Monotherapy.
Status:
COMPLETED
Status Verified Date:
2016-11
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:
BENEFIT
Brief Summary:
This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001143-46 | EUDRACT_NUMBER | None | View |