PMID- 35239165
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220424
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 13
IP  - 3
DP  - 2022 Mar
TI  - Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 
      Diabetes Who Fast During Ramadan in The Gulf Region: A Subgroup Analysis of the 
      Real-World ORION Study.
PG  - 569-581
LID - 10.1007/s13300-022-01225-z [doi]
AB  - INTRODUCTION: To evaluate the safety and effectiveness of insulin glargine 300 
      U/mL (Gla-300) in people with type 2 diabetes mellitus (T2DM) in the Gulf region 
      who fast during Ramadan. METHODS: ORION was a real-world, prospective, 
      observational study in people with T2DM treated with Gla-300 during pre-Ramadan, 
      Ramadan, and post-Ramadan periods. This subgroup analysis included 222 
      participants from the Gulf region (Kuwait, Saudi Arabia, United Arab Emirates, 
      and Qatar). The primary endpoint was the percentage of participants experiencing 
      severe and/or symptomatic documented hypoglycemia (self-monitored plasma glucose 
      [SMPG] </= 70 mg/dL) during Ramadan. Changes in glycated hemoglobin (HbA(1c)), 
      fasting plasma glucose (FPG), SMPG, body weight, insulin dose, and adverse events 
      (AEs) were also evaluated. RESULTS: The primary endpoint was reported in one 
      (0.5%) participant during Ramadan. The incidence rate of symptomatic documented 
      hypoglycemia (SMPG </= 70 mg/dL) decreased from the pre-Ramadan (3.2%) to Ramadan 
      period (0.5%), and no severe hypoglycemia events were reported during the study. 
      Reductions were observed in HbA(1c) (mean +/- standard deviation: - 0.51 +/- 0.95% 
      [- 5.5 +/- 10.4 mmol/mol]), FPG (- 13.9 +/- 47.5 mg/dL), and SMPG 
      (- 6.1 +/- 27.1 mg/dL). No significant changes were observed in body weight or 
      Gla-300 dose. AEs were reported in 11 (5.0%) participants. CONCLUSION: In a 
      real-world setting in the Gulf region, Gla-300 treatment in people with T2DM 
      during Ramadan was associated with a low incidence of hypoglycemia and improved 
      glycemic control. TRIAL REGISTRATION: CTRI/2019/02/017636.
CI  - (c) 2022. The Author(s).
FAU - Malik, Rayaz A
AU  - Malik RA
AD  - Weill Cornell Medicine - Qatar, Education City, Doha, Qatar.
FAU - Elhadd, Tarik
AU  - Elhadd T
AD  - Endocrine Section, Department of Medicine, Hamad Medical Corporation, Doha, 
      Qatar.
FAU - Alattar, Abdulnabi
AU  - Alattar A
AD  - Internal Medicine Department, Amiri Hospital, Kuwait City, Kuwait.
FAU - Al Shaikh, Abdulrahman
AU  - Al Shaikh A
AD  - King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
FAU - Al Randi, Muneera
AU  - Al Randi M
AD  - Family Medicine Clinic, New Mowasat Hospital, Salmiya, 22077, Kuwait.
FAU - Arora, Ravi
AU  - Arora R
AD  - NMC Specialty Hospital, Abu Dhabi, United Arab Emirates.
FAU - Al-Sifri, Saud
AU  - Al-Sifri S
AD  - Endocrinology Department, Al Hada Military Hospital, Taif, Saudi Arabia.
FAU - Akil, Yasser
AU  - Akil Y
AD  - Sanofi, Jeddah, Saudi Arabia.
FAU - Magdy, Amr
AU  - Magdy A
AD  - Sanofi, Dubai, United Arab Emirates.
FAU - Naqvi, Mubarak
AU  - Naqvi M
AD  - Sanofi, Mumbai, Maharashtra, India.
FAU - Hassanein, Mohamed
AU  - Hassanein M
AUID- ORCID: 0000-0001-6598-6972
AD  - Dubai Hospital, Dubai Health Authority, Al Khaleej Street, Al Baraha, 7272, 
      Dubai, United Arab Emirates. mhassanein148@hotmail.com.
LA  - eng
SI  - CTRI/CTRI/2019/02/017636
PT  - Journal Article
DEP - 20220303
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC8934889
OTO - NOTNLM
OT  - Fasting
OT  - Gulf
OT  - Hypoglycemia
OT  - Insulin glargine 300 U/mL
OT  - Ramadan
OT  - Type 2 diabetes mellitus
EDAT- 2022/03/04 06:00
MHDA- 2022/03/04 06:01
PMCR- 2022/03/03
CRDT- 2022/03/03 12:20
PHST- 2021/12/24 00:00 [received]
PHST- 2022/02/04 00:00 [accepted]
PHST- 2022/03/04 06:00 [pubmed]
PHST- 2022/03/04 06:01 [medline]
PHST- 2022/03/03 12:20 [entrez]
PHST- 2022/03/03 00:00 [pmc-release]
AID - 10.1007/s13300-022-01225-z [pii]
AID - 1225 [pii]
AID - 10.1007/s13300-022-01225-z [doi]
PST - ppublish
SO  - Diabetes Ther. 2022 Mar;13(3):569-581. doi: 10.1007/s13300-022-01225-z. Epub 2022 
      Mar 3.