Comparison of the Impact of Insulin Degludec U100 and Insulin Glargine U300 on Glycemic Variability and Oxidative Stress in Insulin-Naive Patients With Type 2 Diabetes Mellitus: Pilot Study for a Randomized Trial.
RCT
clinical trial
control trial
diabetes
diabetic
glucose variability
glycaemic variability
glycemic variability
insulin
insulin degludec
insulin glargine U300
oxidative stress
pilot
type 2 diabetes mellitus
type two diabetes mellitus
Journal
JMIR formative research
ISSN: 2561-326X
Titre abrégé: JMIR Form Res
Pays: Canada
ID NLM: 101726394
Informations de publication
Date de publication:
08 Jul 2022
08 Jul 2022
Historique:
received:
12
12
2021
accepted:
01
06
2022
revised:
30
05
2022
entrez:
8
7
2022
pubmed:
9
7
2022
medline:
9
7
2022
Statut:
epublish
Résumé
There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300). There is little data and head-to-head comparison of IDeg-100 and IGlar-300 regarding their simultaneous impact on glycemic variability and oxidative stress in patients with type 2 diabetes mellitus (T2DM). In our randomized, open-label, crossover study, we compared the impact of IDeg-100 and IGlar-300 on glycemic variability and oxidative stress in insulin-naive patients with T2DM. We recruited a total of 25 adult patients with T2DM (7 females) whose diabetes was uncontrolled (HbA IGlar-300 reduced mean glucose by 0.02-0.13 mmol/L, and IDeg-100 reduced glucose by 0.10-0.16 mmol/L, with no significant difference. The reduction of the coefficient of glucose variation also did not show a statistically significant difference. IGlar-300 increased thiols by 0.08 µmol/L and IDeg-100 increased thiols by 0.15 µmol/L, with no significant difference (P=.07) between them. IGlar-300 reduced hydroperoxides by 0.040 CARR U and IDeg-100 increased hydroperoxides by 0.034 CARR U, but the difference was not significant (P=.12). The results of our study do not show a significant difference regarding glycemic variability between patients receiving either insulin IDeg-100 or IGlar-300, although IGlar-300 showed greater dispersion of data. No significant difference in oxidative stress was observed. In a larger study, doses of insulins should be higher to achieve significant impact on glycemic parameters and consequently on glycemic variability and oxidative stress. ClinicalTrials.gov, NCT04692415; https://clinicaltrials.gov/ct2/show/NCT04692415.
Sections du résumé
BACKGROUND
BACKGROUND
There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300). There is little data and head-to-head comparison of IDeg-100 and IGlar-300 regarding their simultaneous impact on glycemic variability and oxidative stress in patients with type 2 diabetes mellitus (T2DM).
OBJECTIVE
OBJECTIVE
In our randomized, open-label, crossover study, we compared the impact of IDeg-100 and IGlar-300 on glycemic variability and oxidative stress in insulin-naive patients with T2DM.
METHODS
METHODS
We recruited a total of 25 adult patients with T2DM (7 females) whose diabetes was uncontrolled (HbA
RESULTS
RESULTS
IGlar-300 reduced mean glucose by 0.02-0.13 mmol/L, and IDeg-100 reduced glucose by 0.10-0.16 mmol/L, with no significant difference. The reduction of the coefficient of glucose variation also did not show a statistically significant difference. IGlar-300 increased thiols by 0.08 µmol/L and IDeg-100 increased thiols by 0.15 µmol/L, with no significant difference (P=.07) between them. IGlar-300 reduced hydroperoxides by 0.040 CARR U and IDeg-100 increased hydroperoxides by 0.034 CARR U, but the difference was not significant (P=.12).
CONCLUSIONS
CONCLUSIONS
The results of our study do not show a significant difference regarding glycemic variability between patients receiving either insulin IDeg-100 or IGlar-300, although IGlar-300 showed greater dispersion of data. No significant difference in oxidative stress was observed. In a larger study, doses of insulins should be higher to achieve significant impact on glycemic parameters and consequently on glycemic variability and oxidative stress.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT04692415; https://clinicaltrials.gov/ct2/show/NCT04692415.
Identifiants
pubmed: 35802405
pii: v6i7e35655
doi: 10.2196/35655
pmc: PMC9308081
doi:
Banques de données
ClinicalTrials.gov
['NCT04692415']
Types de publication
Journal Article
Langues
eng
Pagination
e35655Informations de copyright
©Pavle Vrebalov Cindro, Mladen Krnić, Darko Modun, Jonatan Vuković, Tina Tičinović Kurir, Goran Kardum, Doris Rušić, Ana Šešelja Perišin, Josipa Bukić. Originally published in JMIR Formative Research (https://formative.jmir.org), 08.07.2022.
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