PMID- 32360709
OWN - NLM
STAT- MEDLINE
DCOM- 20201028
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 166
DP  - 2020 Aug
TI  - Real-world safety and effectiveness of insulin glargine 300 U/mL in participants 
      with type 2 diabetes who fast during Ramadan: The observational ORION study.
PG  - 108189
LID - S0168-8227(20)30439-3 [pii]
LID - 10.1016/j.diabres.2020.108189 [doi]
AB  - AIMS: ORION evaluated the safety and effectiveness of Gla-300 in insulin-treated 
      people with T2DM before, during and after Ramadan, in a real-world setting. 
      METHODS: This prospective, observational study across 11 countries included 
      participants with T2DM treated with Gla-300 in pre-Ramadan, Ramadan and 
      post-Ramadan periods. The primary endpoint was the percentage of participants 
      experiencing >/=1 event of severe and/or symptomatic documented hypoglycaemia with 
      self-monitored plasma glucose (SMPG) </=70 mg/dL during Ramadan. Secondary 
      endpoints included change in HbA(1c) and insulin dose and adverse events (AEs). 
      RESULTS: The mean +/- SD number of fasting days was 30.1 +/- 3.2. The percentage of 
      participants experiencing >/=1 event of severe and/or symptomatic documented 
      hypoglycaemia (SMPG </=70 [<54] mg/dL) was low in the pre-Ramadan (2.2% [0.8%]), 
      Ramadan (2.6% [0%]) and post-Ramadan (0.2% [0%]) periods. No participants 
      reported severe hypoglycaemia during Ramadan or post-Ramadan; one participant 
      reported severe hypoglycaemia in pre-Ramadan. HbA(1c) fell pre- to post-Ramadan, 
      and Gla-300 daily dose (mean +/- SD) was reduced pre-Ramadan to Ramadan (from 25.6 
      +/- 11.9 U/0.32 +/- 0.14 U/kg to 24.4 +/- 11.5 U/0.30 +/- 0.13 U/kg). Incidence of AEs 
      was 5.5%. CONCLUSIONS: In ORION, people with T2DM treated with Gla-300 who fasted 
      during Ramadan had a low risk of severe/symptomatic hypoglycaemia and improved 
      glycaemic control.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Hassanein, Mohamed
AU  - Hassanein M
AD  - Dubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates. Electronic 
      address: mhassanein148@hotmail.com.
FAU - Buyukbese, Mehmet Akif
AU  - Buyukbese MA
AD  - Avicenna Hospital, Atasehir, Istanbul, Turkey.
FAU - Malek, Rachid
AU  - Malek R
AD  - Internal Medicine Department, CHU Mohamed Saadna Abdennour, Setif, Algeria.
FAU - Pilorget, Valerie
AU  - Pilorget V
AD  - Sanofi, Paris, France.
FAU - Naqvi, Mubarak
AU  - Naqvi M
AD  - Sanofi, Mumbai, India.
FAU - Berthou, Baptiste
AU  - Berthou B
AD  - Sanofi, Paris, France.
FAU - Shaltout, Inass
AU  - Shaltout I
AD  - Cairo University, Cairo, Egypt.
FAU - Kumar Sahay, Rakesh
AU  - Kumar Sahay R
AD  - Osmania Medical College, Hyderabad, Telangana, India.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20200501
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology
MH  - Dose-Response Relationship, Drug
MH  - Fasting/*physiology
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/chemically induced/epidemiology
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Incidence
MH  - Insulin Glargine/*administration & dosage/*adverse effects
MH  - *Islam
MH  - Male
MH  - Middle Aged
MH  - Religion and Medicine
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Fasting
OT  - Hypoglycaemia
OT  - Insulin glargine 300 U/mL
OT  - Ramadan
OT  - Type 2 diabetes
EDAT- 2020/05/04 06:00
MHDA- 2020/10/29 06:00
CRDT- 2020/05/04 06:00
PHST- 2020/02/07 00:00 [received]
PHST- 2020/04/27 00:00 [accepted]
PHST- 2020/05/04 06:00 [pubmed]
PHST- 2020/10/29 06:00 [medline]
PHST- 2020/05/04 06:00 [entrez]
AID - S0168-8227(20)30439-3 [pii]
AID - 10.1016/j.diabres.2020.108189 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2020 Aug;166:108189. doi: 10.1016/j.diabres.2020.108189. 
      Epub 2020 May 1.