Evidence mapPaperPMID 35076540Full record

ArticleMedical sciences (Basel, Switzerland)2021

Safety of Insulin Degludec/Insulin Aspart in Patients with Diabetes Mellitus over a Period of 1 Year during Routine Clinical Care in India: SMART (Study of Management of Diabetes with Ryzodeg™ Treatment).

Jothydev Kesavadev, Ambanna Gowda, Harish Kumar, Sadasiva Rao Yalamanchi, Sailesh Lodha, Kiran Pal Singh, Debasis Basu, Arthur Asirvatham, Navneet Shah, Muzammil Khan Pathan and 2 more

Open access · goldAbstract read
In one paragraph

Article in Medical sciences (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 38% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Article
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

12 authors at 9 institutions in 1 country.

Jothydev KesavadevJothydev's Diabetes Research Centre, Trivandrum 695032, India.
Ambanna GowdaFortis Hospital, Cunningham Road, Bengaluru 560052, India.
Harish KumarAmrita Institute of Medical Sciences, Kochi 682041, India.
Sadasiva Rao YalamanchiYalamanchi Hospitals & Research Centres Pvt Ltd., Vijayawada 520002, India.
Sailesh LodhaEternal Heart Care Centre, Jaipur 302017, India.
Kiran Pal SinghFortis Hospital, Mohali 160062, India.
Debasis BasuApollo Gleneagles Hospital, Kolkata 700067, India.
Arthur AsirvathamArthur Asirvatham Hospital, Madurai 625020, India.
Navneet ShahSterling Hospital, Ahmedabad 380052, India.
Muzammil Khan PathanNovo Nordisk India Private Limited, Bengaluru 560066, India.
Manjunatha RevannaNovo Nordisk India Private Limited, Bengaluru 560066, India.
Jagat Jyoti MukherjeeApollo Gleneagles Hospital, Kolkata 700067, India.ORCID 0000-0001-7555-0822
Apollo Gleneagles Hospitals · INNovo Nordisk (India) · INAmrita Institute of Medical Sciences and Research Centre · INArthur Asirvatham Hospital · INEternal Hospital · INFortis Hospital · INFortis Hospital · INJothydev's Diabetes and Research Center · INSterling Hospitals · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This post-authorization study was conducted to evaluate the safety of insulin degludec/insulin aspart (IDegAsp) in adult patients with diabetes mellitus (DM) during routine clinical care under a real-world setting in India. Eligible patients received IDegAsp for a minimum of 12 months during routine clinical management. Data were collected at 0, 3, 6, and 12 months. In total, 1029 adult patients with DM were included; 65.2% (n = 671) were men; mean age was 55.0 ± 12.2 years, and the mean duration of diabetes mellitus was 10.8 ± 7.4 years. Thirty adverse events were reported in 23 patients (2.2%) during the follow-up: two adverse events in two patients were serious with fatal outcomes, which were unrelated to IDegAsp use. At baseline, there were 176 confirmed hypoglycemic events in 67 (6.7%) patients while they were on their previous treatment options. At 12 months of treatment with IDegAsp, 11 confirmed hypoglycemic events were reported in 11 (1.1%) patients since the previous visit; there were no reported episodes of severe hypoglycemia. Mean glycosylated hemoglobin value reduced from 9.5% ± 1.8% at baseline to 7.7% ± 1.1% at 12 months. This study showed the safety of IDegAsp in patients with diabetes mellitus over a period of 1 year during routine clinical care.

Indexed as

Diabetes MellitusInsulin AspartAdultAgedBlood GlucoseFemaleHumansHypoglycemic AgentsIndiaInsulin, Long-ActingMaleMiddle AgedBlood GlucoseHypoglycemic AgentsInsulin Aspartinsulin degludecInsulin, Long-Actingdiabetes mellitusglycemic controlIDegAspIndiainsulin therapysafety

Identifiers

PMID35076540
PMCPMC8788540
OpenAlexW4200320010

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.