Researchers from HealthCore Inc. Report Details of New Studies and Findings in the Area of Type 2 Diabetes [Study Design and Baseline Profile for Adults With Type 2 Diabetes In the Once-weekly Subcutaneous Semaglutide Randomized Pragmatic …]: Nutritional and Metabolic Diseases and Conditions – Type 2 Diabetes

2023 JUN 30 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- New research on Nutritional and Metabolic Diseases and Conditions - Type 2 Diabetes is the subject of a report. According to news reporting originating in Wilmington, Delaware, by NewsRx journalists, research stated, “Once-weekly subcutaneous semaglutide, a glucagon-like peptide-1 analog, is approved in the USA as an adjunct to diet and exercise for adults with inadequately controlled type 2 diabetes (T2D) to improve glycemic control and reduce the risk of major adverse cardiovascular events in people with T2D and established cardiovascular disease. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) phase III clinical trial program demonstrated the efficacy and safety of once-weekly subcutaneous semaglutide; however, determining its effectiveness in a real-world setting could support decision-making by clinicians, payers and policy makers in routine clinical practice.”

Financial support for this research came from Novo Nordisk.

The news reporters obtained a quote from the research from HealthCore Inc., “Research design and methods SEmaglutide PRAgmatic (SEPRA) is an ongoing open-label, randomized, pragmatic clinical trial designed to compare the effects of once-weekly subcutaneous semaglutide versus standard of care in US health-insured adults with T2D and physician-determined inadequate glycemic control. The primary end point is the proportion of participants achieving glycated hemoglobin (HbA1c) <7.0% at year 1; other key outcomes include glycemic control, weight loss, healthcare utilization, and patient-reported outcomes. Individual-level data will be collected from routine clinical practice and health insurance claims. The last patient last visit is expected by June 2023. Between July 2018 and March 2021, 1278 participants were enrolled from 138 study sites across the USA. At baseline, 54% were male with mean +/- SD age 57.4 +/- 11.1 years and body mass index 35.7 +/- 8.0 kg/m(2). Mean diabetes duration was 7.4 +/- 6.0 years and mean HbA1c was 8.5 +/- 1.6%. At baseline, concomitant antidiabetes medications included metformin, sulfonylureas, sodium-glucose co-transporter-2 inhibitors, and dipeptidyl peptidase-4 inhibitors. The majority of participants had hypertension and dyslipidemia. The trial design was self-assessed using the PRagmatic Explanatory Continuum Indicator Summary-2 tool by the study steering group and was scored 4-5 in all domains suggesting a highly pragmatic study.”

According to the news reporters, the research concluded: “SEPRA, a highly pragmatic ongoing study, will provide data on the effects of once-weekly subcutaneous semaglutide in a real-world setting when used during routine management of T2D.”

For more information on this research see: Study Design and Baseline Profile for Adults With Type 2 Diabetes In the Once-weekly Subcutaneous Semaglutide Randomized Pragmatic (Sepra) Trial. BMJ Open Diabetes Research & Care, 2023;11(3). BMJ Open Diabetes Research & Care can be contacted at: Bmj Publishing Group, British Med Assoc House, Tavistock Square, London WC1H 9JR, England.

Our news correspondents report that additional information may be obtained by contacting Vincent J. Willey, HealthCore Inc., Sci Affairs, Wilmington, DE 19801, United States. Additional authors for this research include John B. Buse, Helene Nordahl Christensen, Benjamin P. Soule, Emily Zacherle, Brian J. Harty, Julie Mitchell and Mark Cziraky.

The direct object identifier (DOI) for that additional information is: https://doi.org/10.1136/bmjdrc-2022-003206. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.

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