The differences between insulin glargine U300 and insulin degludec U100 in impact on the glycaemic variability, arterial stiffness and the lipid profiles in insulin naïve patients suffering from type two diabetes mellitus - outcomes from cross-over open-label randomized trial.
Aged
Blood Glucose
/ drug effects
Croatia
Cross-Over Studies
Diabetes Mellitus, Type 2
/ drug therapy
Dose-Response Relationship, Drug
Female
Glycated Hemoglobin
/ analysis
Humans
Insulin Glargine
/ administration & dosage
Insulin, Long-Acting
/ administration & dosage
Lipid Metabolism
/ drug effects
Lipids
/ blood
Male
Middle Aged
Treatment Outcome
Vascular Stiffness
/ drug effects
Arterial stiffness
Degludec
Diabetes mellitus type 2
Glargine U300
Glucose variability
Lipids
Journal
BMC endocrine disorders
ISSN: 1472-6823
Titre abrégé: BMC Endocr Disord
Pays: England
ID NLM: 101088676
Informations de publication
Date de publication:
29 Apr 2021
29 Apr 2021
Historique:
received:
18
01
2021
accepted:
12
04
2021
entrez:
30
4
2021
pubmed:
1
5
2021
medline:
27
11
2021
Statut:
epublish
Résumé
Diabetes mellitus type two is one of the major cardiovascular risk factors. Treatment of diabetes can reduce this risk, but the treatment options differ a lot in their risk-reducing capabilities. We compared the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), arterial stiffness and lipid parameters - in insulin naive patients with DMT2. To 23 individuals who previously had uncontrolled DMT2 on two or more oral antidiabetic drugs, IGlar-300 and IDeg-100 were applied for 12 weeks and then switched in a cross over design manner. Prior and after of each insulin phase, we analysed biochemical parameters,7-point SMBG profile over three days and arterial stiffness which was assessed indirectly by measuring the augmentation index (AIx) on the principles of applanation tonometry. There were no significant differences between IGlar-300 and IDeg-100 regarding reduction of mean glucose values and coefficient of variation (CV). Both insulins insignificantly reduced AIx for standardised pulse of 75 beats/min and without differences between them. IGlar-300 and IDeg-100 reduced triglycerides and increased HDL with no significant difference between the two insulins. IGlar-300 increased the total cholesterol level and IDeg-100 decreased total cholesterol, but without statistically significant difference. IGlar-300 increased LDL level by 0.508 mmol/L and IDeg-100 decreased LDL by 0.217 mmol/L, with statistically significant difference (p = 0.0215). This study did not show significant difference between IGlar-300 and IDeg-100 regarding glycaemic parameters and augmentation index using the same dose of 0.2 IU/kg for both insulins, but it has revealed possible differences in impact on lipid profile. Clinicaltrials.gov, NCT04692415 . Retrospectively registered on December 31th 2020.
Sections du résumé
BACKGROUND AND AIMS
OBJECTIVE
Diabetes mellitus type two is one of the major cardiovascular risk factors. Treatment of diabetes can reduce this risk, but the treatment options differ a lot in their risk-reducing capabilities. We compared the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), arterial stiffness and lipid parameters - in insulin naive patients with DMT2.
METHODS
METHODS
To 23 individuals who previously had uncontrolled DMT2 on two or more oral antidiabetic drugs, IGlar-300 and IDeg-100 were applied for 12 weeks and then switched in a cross over design manner. Prior and after of each insulin phase, we analysed biochemical parameters,7-point SMBG profile over three days and arterial stiffness which was assessed indirectly by measuring the augmentation index (AIx) on the principles of applanation tonometry.
RESULTS
RESULTS
There were no significant differences between IGlar-300 and IDeg-100 regarding reduction of mean glucose values and coefficient of variation (CV). Both insulins insignificantly reduced AIx for standardised pulse of 75 beats/min and without differences between them. IGlar-300 and IDeg-100 reduced triglycerides and increased HDL with no significant difference between the two insulins. IGlar-300 increased the total cholesterol level and IDeg-100 decreased total cholesterol, but without statistically significant difference. IGlar-300 increased LDL level by 0.508 mmol/L and IDeg-100 decreased LDL by 0.217 mmol/L, with statistically significant difference (p = 0.0215).
CONCLUSIONS
CONCLUSIONS
This study did not show significant difference between IGlar-300 and IDeg-100 regarding glycaemic parameters and augmentation index using the same dose of 0.2 IU/kg for both insulins, but it has revealed possible differences in impact on lipid profile.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov, NCT04692415 . Retrospectively registered on December 31th 2020.
Identifiants
pubmed: 33926446
doi: 10.1186/s12902-021-00746-1
pii: 10.1186/s12902-021-00746-1
pmc: PMC8082786
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Insulin, Long-Acting
0
Lipids
0
Insulin Glargine
2ZM8CX04RZ
insulin degludec
54Q18076QB
Banques de données
ClinicalTrials.gov
['NCT04692415']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
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