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)
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 advers...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-06-01
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| Series: | Metabolism Open |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589936822000226 |
| _version_ | 1818470258185338880 |
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| author | Jothydev Kesavadev L.Sreenivasa Murthy Tirthankar Chaudhury Sadasiva Rao Yalamanchi J. Giri Sunil Gupta Sanjeev Phatak K.D. Modi Sanjay Chatterjee Aparna Manjunath Manjunatha Revanna Arpandev Bhattacharya |
| author_facet | Jothydev Kesavadev L.Sreenivasa Murthy Tirthankar Chaudhury Sadasiva Rao Yalamanchi J. Giri Sunil Gupta Sanjeev Phatak K.D. Modi Sanjay Chatterjee Aparna Manjunath Manjunatha Revanna Arpandev Bhattacharya |
| author_sort | Jothydev Kesavadev |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T21:35:06Z |
| format | Article |
| id | doaj.art-30e9990337e941b0ae9353e2ae94d63e |
| institution | Directory Open Access Journal |
| issn | 2589-9368 |
| language | English |
| last_indexed | 2024-04-13T21:35:06Z |
| publishDate | 2022-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Metabolism Open |
| spelling | doaj.art-30e9990337e941b0ae9353e2ae94d63e2022-12-22T02:29:00ZengElsevierMetabolism Open2589-93682022-06-0114100184One-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 Kesavadev0L.Sreenivasa Murthy1Tirthankar Chaudhury2Sadasiva Rao Yalamanchi3J. Giri4Sunil Gupta5Sanjeev Phatak6K.D. Modi7Sanjay Chatterjee8Aparna Manjunath9Manjunatha Revanna10Arpandev Bhattacharya11Jothydev’s Diabetes Research Centre, Thiruvananthapuram, Kerala, IndiaLife Care Hospital & Research Centre, Bengaluru, Karnataka, IndiaApollo Gleneagles Hospital, Kolkata, West Bengal, IndiaYalamanchi Hospitals & Research Centres Pvt. Ltd, Vijayawada, Andhra Pradesh, IndiaKG Hospital, Coimbatore, Tamil Nadu, IndiaSunil’s Diabetes Care & Research Centre Pvt. Ltd, Nagpur, Maharashtra, IndiaVijayratna Diabetes Diagnostic Treatment Centre, Ahmedabad, Gujarat, IndiaCare Hospitals, Hyderabad, Telangana, IndiaApollo Gleneagles Hospital, Kolkata, West Bengal, IndiaNovo Nordisk India Private Limited, Bengaluru, Karnataka, IndiaNovo Nordisk India Private Limited, Bengaluru, Karnataka, IndiaManipal Hospital, Bengaluru, Karnataka, India; Corresponding author. Department of Diabetes and Endocrinology, Manipal Hospital, Bengaluru, Karnataka, India.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.http://www.sciencedirect.com/science/article/pii/S2589936822000226Insulin degludecDiabetes mellitusSafetyPost-authorization safety studyEffectivenessReal-world evidence |
| spellingShingle | Jothydev Kesavadev L.Sreenivasa Murthy Tirthankar Chaudhury Sadasiva Rao Yalamanchi J. Giri Sunil Gupta Sanjeev Phatak K.D. Modi Sanjay Chatterjee Aparna Manjunath Manjunatha Revanna Arpandev Bhattacharya 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) Metabolism Open Insulin degludec Diabetes mellitus Safety Post-authorization safety study Effectiveness Real-world evidence |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Insulin degludec Diabetes mellitus Safety Post-authorization safety study Effectiveness Real-world evidence |
| url | http://www.sciencedirect.com/science/article/pii/S2589936822000226 |
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