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Tytuł pozycji:

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.

Tytuł:
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.
Autorzy:
Hassanein M; Dubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates. Electronic address: .
Buyukbese MA; Avicenna Hospital, Atasehir, Istanbul, Turkey.
Malek R; Internal Medicine Department, CHU Mohamed Saadna Abdennour, Sétif, Algeria.
Pilorget V; Sanofi, Paris, France.
Naqvi M; Sanofi, Mumbai, India.
Berthou B; Sanofi, Paris, France.
Shaltout I; Cairo University, Cairo, Egypt.
Kumar Sahay R; Osmania Medical College, Hyderabad, Telangana, India.
Źródło:
Diabetes research and clinical practice [Diabetes Res Clin Pract] 2020 Aug; Vol. 166, pp. 108189. Date of Electronic Publication: 2020 May 01.
Typ publikacji:
Journal Article; Multicenter Study; Observational Study
Język:
English
Imprint Name(s):
Publication: 1993- : Limerick : Elsevier Scientific Publishers
Original Publication: Amsterdam : Elsevier Science Publishers B.V., c1985-
MeSH Terms:
Islam*
Diabetes Mellitus, Type 2/*drug therapy
Fasting/*physiology
Insulin Glargine/*administration & dosage
Insulin Glargine/*adverse effects
Adult ; Aged ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/epidemiology ; Dose-Response Relationship, Drug ; Female ; Glycated Hemoglobin/analysis ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemia/epidemiology ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/adverse effects ; Incidence ; Male ; Middle Aged ; Religion and Medicine ; Treatment Outcome
Contributed Indexing:
Keywords: Fasting; Hypoglycaemia; Insulin glargine 300 U/mL; Ramadan; Type 2 diabetes
Substance Nomenclature:
0 (Blood Glucose)
0 (Glycated Hemoglobin A)
0 (Hypoglycemic Agents)
2ZM8CX04RZ (Insulin Glargine)
Entry Date(s):
Date Created: 20200504 Date Completed: 20201028 Latest Revision: 20221207
Update Code:
20240105
DOI:
10.1016/j.diabres.2020.108189
PMID:
32360709
Czasopismo naukowe
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.
(Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

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