Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-16 @ 7:26 AM
Study NCT ID:
NCT02219750
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2014-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients
Sponsor:
Mackay Memorial Hospital
Organization:
Study Overview
Official Title:
Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
Status:
COMPLETED
Status Verified Date:
2016-03
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:
COMPAR
Brief Summary:
Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes
Detailed Description:
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a 1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. All study procedure will be conducted after obtaining informed consent.
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?: