Evidence map›Paper›PMID 33926446›Full record

Trial reportBMC endocrine disorders2021

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

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC endocrine disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04692415 (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 naïve Patients Suffering From Type Two Diabetes Mellitus), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04692415 phase4completednot on this map

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 naïve Patients Suffering From Type Two Diabetes Mellitus

TypeinterventionalSponsorUniversity of Split, School of MedicineRan2018 to 2019Enrolled25ConditionsDiabetes Mellitus, Type 2ArmsDegludec, Glargine U300
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. The Role of Glycemic Variability in Cardiovascular Disorders.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Pavle Vrebalov CindroDepartment of Gastroenterology, University Hospital Split, Spinčićeva 1, 21000, Split, Croatia.
Mladen KrnićDepartment of Endocrinology, University Hospital Split, Šoltanska 1, 21000, Split, Croatia. mladen.krnic@gmail.com.
Darko ModunDepartment of Pharmacy, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.
Božo SmajićMedical Student, University of Split School of Medicine, Šoltanska 2, 21000, Split, Croatia.
Jonatan VukovićDepartment of Gastroenterology, University Hospital Split, Spinčićeva 1, 21000, Split, Croatia.
University of Split · HR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsDiabetes 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.

methodsTo 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.

resultsThere 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).

conclusionsThis 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 registrationClinicaltrials.gov, NCT04692415 . Retrospectively registered on December 31th 2020.

Indexed as

AgedBlood GlucoseCroatiaCross-Over StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleGlycated HemoglobinHumansInsulin GlargineInsulin, Long-ActingLipid MetabolismLipidsMaleMiddle AgedTreatment OutcomeBlood GlucoseGlycated Hemoglobininsulin degludecInsulin GlargineInsulin, Long-ActingLipidsArterial stiffnessDegludecDiabetes mellitus type 2Glargine U300Glucose variabilityLipids

Identifiers

PMID33926446
PMCPMC8082786
OpenAlexW3158986176

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.