Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692415
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2020-12-20
Brief Title:
Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
Sponsor:
University of Split School of Medicine
Organization:
University of Split School of Medicine
Study Overview
Official Title:
The Differences Between Insulin Glargine U300 and Insulin Degludec U100 in Impact on the Glycaemic Variability Oxidative Stress Arterial Stiffness and the Lipid Profiles in Insulin naive Patients Suffering From Type Two Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2020-12
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:
To compare the impact of insulin degludec IDeg-100 and insulin glargine U300 IGlar-300 on cardiovascular risk parameters - glycaemic variability GV oxidative stress arterial stiffness and lipid parameters - in insulin naive patients with DMT2
Detailed Description:
We recruited a total of 25 patients 23 completed the study with T2DM who had uncontrolled disease on two or more oral antidiabetic drugs After the wash-up period they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin Each insulin was applied for 12 weeks At the beginning and the end of each phase biochemical and oxidative stress parameters were analysed and augmentation index was measured On three consecutive days prior to each control point patients performed a 7-point SMBG profile Oxidative stress was assessed by measuring thiol groups and hydroperoxides d-ROM in serum For augmentation index measuring we used SphygmoCor AtCor Medical Sydney Australia which allow non-invasive measurement of AIx on radial artery using strain gauge transducer placed on the tip of a pencil-type tonometer This method is based on the principle of applanation tonometry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None