Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-02-08 @ 4:33 AM
Study NCT ID:
NCT02449603
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes : a Randomised Open Parallel-controlled Study
Status:
COMPLETED
Status Verified Date:
2018-11
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:
None
Brief Summary:
This is a multi-centre, open-label, randomized, parallel trial to compare the effect of Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin monotherapy.
Detailed Description:
Studies have showed that fluctuations of glucose seem to have more deleterious effects than sustained hyperglycaemia in the development of diabetic complications. The present randomized controlled trial was designed with primary aim to evaluate glycaemic fluctuation in the comparison between twice-daily Exenatide and other treatment paradigm (e.g. insulin Aspart 30).
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?: