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. 2022 Apr 18:14:100184.
doi: 10.1016/j.metop.2022.100184. eCollection 2022 Jun.

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  1 , L Sreenivasa Murthy  2 , Tirthankar Chaudhury  3 , Sadasiva Rao Yalamanchi  4 , J Giri  5 , Sunil Gupta  6 , Sanjeev Phatak  7 , K D Modi  8 , Sanjay Chatterjee  3 , Aparna Manjunath  9 , Manjunatha Revanna  9 , Arpandev Bhattacharya  10
Affiliations

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 et al. Metabol Open. .

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.

Keywords: Diabetes mellitus; Effectiveness; Insulin degludec; Post-authorization safety study; Real-world evidence; Safety.

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Conflict of interest statement

There was no conflict of interest.

Figures

Fig. 1
Fig. 1
Disposition of patients.
Fig. 2
Fig. 2
Change in glycemic parameters in patients receiving insulin degludec over 12 months. (a) Glycated hemoglobin (HbA1c). (b) Fasting plasma glucose. (c) Postprandial plasma glucose (post-breakfast). (d) Postprandial plasma glucose (post-lunch). EAS: effectiveness analysis set; OAD: oral antidiabetic drugs.
See this image and copyright information in PMC

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