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

Pavle Vrebalov Cindro, Mladen Krnić, Darko Modun, Božo Smajić, Jonatan Vuković, Pavle Vrebalov Cindro, Mladen Krnić, Darko Modun, Božo Smajić, Jonatan Vuković

Abstract

Background and aims: 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: 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: 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: 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: Clinicaltrials.gov, NCT04692415 . Retrospectively registered on December 31th 2020.

Keywords: Arterial stiffness; Degludec; Diabetes mellitus type 2; Glargine U300; Glucose variability; Lipids.

Conflict of interest statement

M.K. received honoraria from Sanofi, NovoNordisk, Elly Lilly, Abbott, MSD, Takeda, Novartis, Boehringer Ingelheim, Servier, Lifescan and Astra Zeneca as a speaker and for attendance at advisory boards. Author does not have any conflict of interests associated with this research.

P.V.C. received honoraria from Abbot, Teva and Takeda as a speaker and a case presenter. Author has no conflict of interests associated with this research.

J.V., B.S. and M.D. declare no conflict of interests associated with this research.

Figures

Fig. 1
Fig. 1
The study protocol
Fig. 2
Fig. 2
Mean glucose change, SD and CV in the1st day. SD = standard deviation, CV = coefficient of variation, IGlar-300 = insulin glargine U300, IDeg-100 = insulin degludec U100.
Fig. 3
Fig. 3
Mean glucose change, SD and CV in the 2nd day. SD = standard deviation, CV = coefficient of variation, IGlar-300 = insulin glargine U300, IDeg-100 = insulin degludec U100.
Fig. 4
Fig. 4
Mean glucose change, SD and CV in the 3rd day. SD = standard deviation, CV = coefficient of variation, IGlar-300 = insulin glargine U300, IDeg-100 = insulin degludec U100.
Fig. 5
Fig. 5
Mean change in augmentation index. AIX = augmentation index, BPM = beats per minute, IGlar-300 = insulin glargine U300, IDeg-100 = insulin degludec U100.
Fig. 6
Fig. 6
Changes in plasma lipids. The only statistically significant difference between two insulins was in the impact on LDL. TG = triglycerides, CH = total cholesterol, HDL = high density protein, LDL = low density protein, IGlar-300 = insulin glargine U300, IDeg-100 = insulin degludec U100. The results are depicted as derivations of absolute values and represented as percentage of change.

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Source: PubMed

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