PMID- 35496980
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2589-9368 (Electronic)
IS  - 2589-9368 (Linking)
VI  - 14
DP  - 2022 Jun
TI  - 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).
PG  - 100184
LID - 10.1016/j.metop.2022.100184 [doi]
LID - 100184
AB  - 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.
CI  - (c) 2022 Published by Elsevier Inc.
FAU - Kesavadev, Jothydev
AU  - Kesavadev J
AD  - Jothydev's Diabetes Research Centre, Thiruvananthapuram, Kerala, India.
FAU - Murthy, L Sreenivasa
AU  - Murthy LS
AD  - Life Care Hospital & Research Centre, Bengaluru, Karnataka, India.
FAU - Chaudhury, Tirthankar
AU  - Chaudhury T
AD  - Apollo Gleneagles Hospital, Kolkata, West Bengal, India.
FAU - Yalamanchi, Sadasiva Rao
AU  - Yalamanchi SR
AD  - Yalamanchi Hospitals & Research Centres Pvt. Ltd, Vijayawada, Andhra Pradesh, 
      India.
FAU - Giri, J
AU  - Giri J
AD  - KG Hospital, Coimbatore, Tamil Nadu, India.
FAU - Gupta, Sunil
AU  - Gupta S
AD  - Sunil's Diabetes Care & Research Centre Pvt. Ltd, Nagpur, Maharashtra, India.
FAU - Phatak, Sanjeev
AU  - Phatak S
AD  - Vijayratna Diabetes Diagnostic Treatment Centre, Ahmedabad, Gujarat, India.
FAU - Modi, K D
AU  - Modi KD
AD  - Care Hospitals, Hyderabad, Telangana, India.
FAU - Chatterjee, Sanjay
AU  - Chatterjee S
AD  - Apollo Gleneagles Hospital, Kolkata, West Bengal, India.
FAU - Manjunath, Aparna
AU  - Manjunath A
AD  - Novo Nordisk India Private Limited, Bengaluru, Karnataka, India.
FAU - Revanna, Manjunatha
AU  - Revanna M
AD  - Novo Nordisk India Private Limited, Bengaluru, Karnataka, India.
FAU - Bhattacharya, Arpandev
AU  - Bhattacharya A
AD  - Manipal Hospital, Bengaluru, Karnataka, India.
LA  - eng
PT  - Journal Article
DEP - 20220418
PL  - England
TA  - Metabol Open
JT  - Metabolism open
JID - 101767753
PMC - PMC9046940
OTO - NOTNLM
OT  - Diabetes mellitus
OT  - Effectiveness
OT  - Insulin degludec
OT  - Post-authorization safety study
OT  - Real-world evidence
OT  - Safety
COIS- There was no conflict of interest.
EDAT- 2022/05/03 06:00
MHDA- 2022/05/03 06:01
PMCR- 2022/04/18
CRDT- 2022/05/02 06:57
PHST- 2022/02/14 00:00 [received]
PHST- 2022/04/11 00:00 [revised]
PHST- 2022/04/14 00:00 [accepted]
PHST- 2022/05/02 06:57 [entrez]
PHST- 2022/05/03 06:00 [pubmed]
PHST- 2022/05/03 06:01 [medline]
PHST- 2022/04/18 00:00 [pmc-release]
AID - S2589-9368(22)00022-6 [pii]
AID - 100184 [pii]
AID - 10.1016/j.metop.2022.100184 [doi]
PST - epublish
SO  - Metabol Open. 2022 Apr 18;14:100184. doi: 10.1016/j.metop.2022.100184. 
      eCollection 2022 Jun.