Evidence map›Paper›PMID 35752730›Full record

Trial reportAdvances in therapy2022

Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries.

Gregory R Fulcher, Shahid Akhtar, Saleh J Al-Jaser, Johan Medina, Mafauzy Mohamed, Nemencio A Nicodemus, Anne Helene Olsen, Kiran P Singh, Adri Kok

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04042441 (A Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg®), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.4field-weighted citation impact, top 10% 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.

NCT04042441 completednot on this map

A Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg® (Insulin Degludec/Insulin Aspart) in Patients With Type 2 Diabetes Mellitus in a Real-world Setting

TypeobservationalSponsorNovo Nordisk A/SRan2019 to 2020Enrolled1,122ConditionsDiabetes Mellitus, Type 2ArmsInsulin Degludec/Insulin Aspart
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
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  11. Practical guide in using insulin degludec/insulin aspart: A multidisciplinary approach in Malaysia.Malaysian family physician : the official journal of the Academy of Family Physicians of Malaysia · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 7 countries.

Gregory R FulcherDepartment of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, Sydney, NSW, 2065, Australia. greg.fulcher@sydney.edu.au.ORCID http://orcid.org/0000-0001-8782-0420
Shahid AkhtarNovo Nordisk Region Asia Pacific, Dubai, United Arab Emirates.
Saleh J Al-JaserDepartment of Internal Medicine, Specialized Medical Center Hospital, Riyadh, Saudi Arabia.
Johan MedinaNovo Nordisk A/S, Søborg, Denmark.
Mafauzy MohamedDepartment of Medicine, Hospital Universiti Sains Malaysia, Kota Bharu, Kelantan, Malaysia.
Nemencio A NicodemusDepartment of Biochemistry and Molecular Biology, University of the Philippines-College of Medicine, Manila, Philippines.
Anne Helene OlsenNovo Nordisk A/S, Søborg, Denmark.
Kiran P SinghDepartment of Endocrinology, Fortis Hospital, Mohali, Punjab, India.
Adri KokNetcare Union and Clinton Hospitals, Alberton, South Africa.
Novo Nordisk (Denmark) · DKFortis Hospital · INHospital Universiti Sains Malaysia · MYRiyadh Armed Forces Hospital · SAThe University of Sydney · AUUniversity of the Philippines Manila · PHUniversity of the Witwatersrand · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInsulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting.

methodsThis 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal-bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice.

resultsCompared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26-36; estimated change - 1.4% [95% CI - 1.51; - 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (- 2.7 mmol/L [95% CI - 2.98; - 2.46]; P < 0.0001), body weight (- 1.0 kg [95% CI - 1.51; - 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (- 2.3 units [95% CI - 3.51; - 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS.

conclusionIn adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia.

trial registrationClinical trial registration NCT04042441.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaAdultBlood GlucoseDrug CombinationsGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin AspartInsulin, Long-ActingProspective StudiesBlood GlucoseDrug CombinationsGlycated HemoglobinHypoglycemic AgentsInsulinInsulin Aspartinsulin degludecInsulin, Long-ActingGlycaemic controlInsulin degludec/insulin aspartReal-worldType 2 diabetes

Identifiers

PMID35752730
PMCPMC9244059
OpenAlexW4283458401

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.