Evidence mapPaperPMID 35286607Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2022

A Real-World Observational Study of Gla-300 in Adults with Type 2 Diabetes Who Fast During Ramadan in the South Asia Region: A Subgroup Analysis of the ORION Study.

Mohamed Hassanein, Rakesh Sahay, Mohammad I Hasan, Arshad Hussain, Vinod Mittal, Riyaz Mohammed, Zaman Shaikh, Faraz Farishta, Senthilnathan Mohanasundaram, Mubarak Naqvi and 2 more

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Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

12 authors.

Mohamed HassaneinDubai Hospital, Dubai Health Authority, 222 Al Khaleej Road, Deira, 7272, Dubai, United Arab Emirates. mhassanein148@hotmail.com.ORCID http://orcid.org/0000-0001-6598-6972
Rakesh SahayOsmania Medical College, Hyderabad, 500095, Telangana, India.
Mohammad I HasanDiabetics Institute of Pakistan, Jail Road, Lahore, 54000, Pakistan.
Arshad HussainNorth West General Hospital, Hayatabad, Peshawar, 25100, Pakistan.
Vinod MittalDelhi Diabetes Care Centre, Sat Nagar, Karol Bagh, Delhi, 110005, India.
Riyaz MohammedEsani Diabetes and Multispeciality Center, Surya Nagar Colony, Toli Chowki, Hyderabad, 500008, Telangana, India.
Zaman ShaikhSir Syed Hospital, Qayyumabad, Karachi, 75640, Pakistan.
Faraz FarishtaF S Endocrine Centre, Santosh Nagar, Hyderabad, 500059, Telangana, India.
Senthilnathan MohanasundaramSanofi, Mumbai, 400072, India.
Mubarak NaqviSanofi, Mumbai, 400072, India.
Arjun NairSanofi, Mumbai, 400072, India.
Zubair AliSanofi, Karachi, 74900, Pakistan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn this ORION study subgroup analysis, the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) was evaluated in people from the South Asia region with type 2 diabetes mellitus (T2DM) before, during, and after Ramadan, in a real-world setting.

methodsThe ORION study was a real-world, prospective, observational, non-comparative study conducted across 11 countries. The current subgroup analysis included participants from the South Asia region (India and Pakistan) who fasted during Ramadan. The primary endpoint was the percentage of participants experiencing ≥ 1 event of severe and/or symptomatic documented hypoglycemia with self-monitored plasma glucose (SMPG) ≤ 70 mg/dL during Ramadan. Secondary endpoints analyzed were changes in glycated hemoglobin (HbA

resultsThis subgroup analysis included 106 participants from the South Asia region with mean (standard deviation) age of 51.3 (10.9) years and mean number of 29.8 (4.0) fasting days. The number of severe and/or symptomatic documented hypoglycemia events was low in the pre-Ramadan (SMPG ≤ 70 mg/dL: 1 event [0.9%]; SMPG < 54 mg/dL: 1 event [0.9%]) and Ramadan periods (SMPG ≤ 70 mg/dL: 1 event [0.9%]; SMPG < 54 mg/dL: 0 events), and none in the post-Ramadan period. One participant reported severe hypoglycemia (any time of the day: nocturnal or daytime) throughout the pre-Ramadan period. A reduction in HbA

conclusionsThe real-world data from the ORION study indicate that Gla-300 is effective, with low risk of hypoglycemia, for the management of T2DM during Ramadan in the South Asian population.

trial registrationCTRI/2019/02/017636.

Indexed as

FastingHypoglycemiaInsulin glargine 300 U/mLRamadanType 2 diabetes mellitus

Identifiers

PMID35286607
PMCPMC8991272

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.