Evidence map›Paper›PMID 35496980›Full record

ArticleMetabolism open2022

One-year safety and effectiveness of insulin degludec in patients with diabetes mellitus in routine clinical practice in India-TRUST (Tresiba real-world use study).

Jothydev Kesavadev, L Sreenivasa Murthy, Tirthankar Chaudhury, Sadasiva Rao Yalamanchi, J Giri, Sunil Gupta, Sanjeev Phatak, K D Modi, Sanjay Chatterjee, Aparna Manjunath and 2 more

Open access · goldAbstract read
In one paragraph

Article in Metabolism open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Economic Evaluation of Once-Weekly Insulin Icodec from Italian NHS Perspective.ClinicoEconomics and outcomes research : CEOR · 2024
    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 8 institutions in 1 country.

Jothydev KesavadevJothydev's Diabetes Research Centre, Thiruvananthapuram, Kerala, India.
L Sreenivasa MurthyLife Care Hospital & Research Centre, Bengaluru, Karnataka, India.
Tirthankar ChaudhuryApollo Gleneagles Hospital, Kolkata, West Bengal, India.
Sadasiva Rao YalamanchiYalamanchi Hospitals & Research Centres Pvt. Ltd, Vijayawada, Andhra Pradesh, India.
J GiriKG Hospital, Coimbatore, Tamil Nadu, India.
Sunil GuptaSunil's Diabetes Care & Research Centre Pvt. Ltd, Nagpur, Maharashtra, India.
Sanjeev PhatakVijayratna Diabetes Diagnostic Treatment Centre, Ahmedabad, Gujarat, India.
K D ModiCare Hospitals, Hyderabad, Telangana, India.
Sanjay ChatterjeeApollo Gleneagles Hospital, Kolkata, West Bengal, India.
Aparna ManjunathNovo Nordisk India Private Limited, Bengaluru, Karnataka, India.
Manjunatha RevannaNovo Nordisk India Private Limited, Bengaluru, Karnataka, India.
Arpandev BhattacharyaManipal Hospital, Bengaluru, Karnataka, India.
Apollo Gleneagles Hospitals · INNovo Nordisk (India) · INCARE Hospitals · INDiabetes Care and Research Foundation · INJothydev's Diabetes and Research Center · INKG Hospital · INManipal Hospital · INSwasthya Diabetes Care · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: This post-authorization safety study (PASS) was conducted to evaluate the long-term safety and effectiveness of insulin degludec in patients with diabetes mellitus (DM) requiring insulin therapy in routine clinical practice in India. Methods: Data on glycated hemoglobin (HbA1c) and adverse events (AEs) were collected up to 12 months after insulin degludec initiation. Results: A total of 1057 adult patients with DM were enrolled, including 60.07% males with the mean duration of 22.2 ± 21.90 years with type 1 DM and 10.1 ± 7.37 years with type 2 DM and the mean HbA1c of 9.6 ± 1.9%. Insulin degludec was prescribed to improve HbA1c and fasting plasma glucose (FPG). Insulin degludec daily dose was increased from 14.8 ± 8.0 U to 18.0 ± 9.46 U over 12 months resulting in a significant decrease of HbA1c by 1.8 ± 1.68% compared with baseline. There were 84 events of confirmed hypoglycemia in 51 patients during the 12-month follow-up period, and 44 AEs were reported in 2.6% of patients, of which 2 AEs were serious and unrelated to the drug. Conclusion: Insulin degludec is well tolerated in patients with DM. It improves glycemic control with reduced HbA1c, FPG, and postprandial glucose, with a low risk of hypoglycemia.

Indexed as

Diabetes mellitusEffectivenessInsulin degludecPost-authorization safety studyReal-world evidenceSafety

Identifiers

PMID35496980
PMCPMC9046940
OpenAlexW4225297177

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.