Evidence mapPaperPMID 35802405Full record

ArticleJMIR formative research2022

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.

Pavle Vrebalov Cindro, Mladen Krnić, Darko Modun, Jonatan Vuković, Tina Tičinović Kurir, Goran Kardum, Doris Rušić, Ana Šešelja Perišin, Josipa Bukić

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR formative research, 2022. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 50% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

9 authors at 1 institution in 1 country.

Pavle Vrebalov CindroDepartment of Gastroenterology, University Hospital Split, Split, Croatia.ORCID https://orcid.org/0000-0002-1334-2160
Mladen KrnićDepartment of Endocrinology, University Hospital Split, Split, Croatia.ORCID https://orcid.org/0000-0002-3676-1608
Darko ModunDepartment of Pharmacy, School of Medicine, University of Split, Split, Croatia.ORCID https://orcid.org/0000-0001-9508-9383
Jonatan VukovićDepartment of Gastroenterology, University Hospital Split, Split, Croatia.ORCID https://orcid.org/0000-0002-7878-7988
Tina Tičinović KurirDepartment of Endocrinology, University Hospital Split, Split, Croatia.ORCID https://orcid.org/0000-0001-5975-5393
Goran KardumDepartment of Psychology, Faculty of Humanities and Social Sciences, University of Split, Split, Croatia.ORCID https://orcid.org/0000-0002-5766-361X
Doris RušićDepartment of Pharmacy, School of Medicine, University of Split, Split, Croatia.ORCID https://orcid.org/0000-0002-7018-4947
Ana Šešelja PerišinDepartment of Pharmacy, School of Medicine, University of Split, Split, Croatia.ORCID https://orcid.org/0000-0001-7927-5311
Josipa BukićDepartment of Pharmacy, School of Medicine, University of Split, Split, Croatia.ORCID https://orcid.org/0000-0002-9316-5538
University of Split · HR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere 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).

objectiveIn 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.

methodsWe recruited a total of 25 adult patients with T2DM (7 females) whose diabetes was uncontrolled (HbA

resultsIGlar-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).

conclusionsThe 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 registrationClinicalTrials.gov, NCT04692415; https://clinicaltrials.gov/ct2/show/NCT04692415.

Indexed as

clinical trialcontrol trialdiabetesdiabeticglucose variabilityglycaemic variabilityglycemic variabilityinsulininsulin degludecinsulin glargine U300oxidative stresspilotRCTtype 2 diabetes mellitustype two diabetes mellitus

Identifiers

PMID35802405
PMCPMC9308081
OpenAlexW4284967116

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.