Accepted for/Published in: JMIR Formative Research
Date Submitted: Dec 12, 2021
Open Peer Review Period: Dec 12, 2021 - Feb 6, 2022
Date Accepted: Jun 1, 2022
(closed for review but you can still tweet)
Comparison of the impact of Insulin Degludec U100 and Insulin Glargine U300 on the glycaemic variability and the oxidative stress in insulin naïve patients with diabetes mellitus type two – initial (pilot) study for randomized trial
ABSTRACT
Background:
There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300).
Objective:
In our study, we compared the impact of IDeg-100 and IGlar-300 on glycaemic variability and oxidative stress in insulin naive patients with T2DM.
Methods:
We recruited a total of 25 adult patients (7 females), of which 22 completed the study, with T2DM, who had uncontrolled disease on two or more oral antidiabetic drugs. Mean age was 57.3 (±6.99) years and duration of diabetes was 9.94 (±5.01) years. 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 and then switched. At the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed. 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.
Results:
IGlar-300 reduced mean glucose by 0.02 to 0.13 mmol/L, and IDeg-100 reduced glucose by 0.10 to 0.16 mmol/L, with no significant difference. The reduction of CV also did not show a statistically significant difference. IGlar-300 increased thiols by 0.08 µmol/L and IDeg-100 by 0.15 µmol/L with no significant difference (p=0.07) between them. IGlar-300 reduced hydroperoxides by 0.040 CARR U and IDeg-100 increased d-ROM by 0.034 CARR U, but without significant difference (p=0.12).
Conclusions:
The results of our study do not show a significant difference regarding glycaemic variability between the patients receiving either insulin IDeg-100 or IGlar-300, although IGlar-300 showed greater dispersion of data. No significant difference in the oxidative stress could be observed either. In the larger study doses of insulins should be higher to achieve significant impact on glycemic parameters and consequently on glycaemic variability and oxidative stress. Clinical Trial: Clinicaltrials.gov, NCT04692415 (https://clinicaltrials.gov/ct2/show/NCT04692415)
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