Author: Kick, Anastas ; Amadid, Hanan ; Braae, Uffe Christian ; Acquistapace, Flavio ; Ambühl, Robert A ; Item, Flurin ; Schultes, Bernd ; Rudofsky, Gottfried ; M'Rabet-Bensalah, Khadija ; Züger, Thomas

INTRODUCTIONReal-world data provide insight into how medications perform in clinical practice. The PIONEER REAL Switzerland study aimed to understand clinical outcomes with oral semaglutide in adults with type 2 diabetes (T2D).METHODSPIONEER REAL Switzerland was a 34-44-week, multicentre, prospective, non-interventional, single-arm study of adults with T2D naïve to injectable glucose-lowering medication who were initiated on oral semaglutide in routine clinical practice. The primary endpoint was change in glycated haemoglobin (HbA_1c) from baseline (BL) to end of study (EOS); secondary endpoints included change in body weight (BW) from BL to EOS and the proportion of participants achieving HbA_1c < 7.0% and the composite endpoints HbA_1c reduction ≥ 1%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.RESULTSOf the 185 participants (female/male, n = 67/118) initiating oral semaglutide, 168 (90.8%) completed the study and 143 (77.3%) remained on treatment with oral semaglutide at EOS. At BL, participants had a mean age of 62 years, diabetes duration of 6.4 years, HbA_1c of 7.7%, BW of 95.6 kg and body mass index of 33.2 kg/m²; 56.2% of participants were receiving glucose-lowering medications. Significant reductions were observed for HbA_1c (estimated change - 0.91%; 95% confidence interval [CI] - 1.10, - 0.71; p < 0.0001) and BW (estimated change - 4.85%; 95% CI - 5.70, - 4.00; p < 0.0001). In total, 139 adverse events (AEs) were reported in 65 (35.1%) participants; most were mild or moderate. The most frequent AEs were gastrointestinal disorders (27.0%); 31 AEs in 20 (10.8%) participants led to discontinuation of oral semaglutide. Six serious AEs were reported; all were considered unlikely to be related to oral semaglutide.CONCLUSIONPeople living with T2D treated with oral semaglutide in Switzerland achieved clinically significant reductions in HbA_1c and BW, with no new safety signals.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov: NCT04537624. A graphical abstract is available for this article.

01 Mar 2024·Diabetes, Obesity and Metabolism

Weight loss and treatment patterns in a real‐world population of adults receiving liraglutide 3.0 mg for weight management in routine clinical practice in Switzerland (ADDRESS study)

Article

Author: Timper, Katharina ; Schultes, Bernd ; Rüh, Josefine ; Gerber, Philipp A ; Cavadini, Gionata

AbstractAimTo assess weight loss associated with liraglutide 3.0 mg treatment in individuals with obesity (body mass index [BMI] ≥30 kg/m2) or overweight (BMI > 27 to <30 kg/m2) in a reimbursed, real‐world setting in Switzerland.Materials and MethodsADDRESS was a non‐comparative, multicentre, retrospective exposure cohort study in Switzerland, examining weight loss in individuals with obesity or overweight whose treatment was reimbursed (divided into BMI subgroups) or non‐reimbursed. The primary outcomes were proportions of participants in the reimbursed cohort achieving predefined weight loss targets with liraglutide 3.0 mg at Week 16 (≥5% and ≥7% for the lower BMI [28 to <35 kg/m2 with weight‐related comorbidities] and higher BMI [≥35 kg/m2] subgroups, respectively) and Month 10 (additional ≥5% from Week 16; per Swiss reimbursement criteria).ResultsThe full analysis set comprised 258 individuals (195 reimbursed; 63 non‐reimbursed). In the reimbursed cohort, 139 individuals (71.3%) achieved their weight loss targets at Week 16. Of individuals who met the Week‐16 criteria, 43.2% attained an additional 5% weight loss at Month 10. In 162 individuals for whom data were recorded at Month 10, the mean (standard deviation) relative weight loss from baseline to Month 10 was −12.4% (6.4%).ConclusionsAlthough reimbursement criteria may be difficult to achieve, particularly the additional weight loss of 5% from Week 16 to Month 10, a clinically relevant overall weight loss from baseline to Month 10 was shown in most individuals with obesity or overweight who received liraglutide 3.0 mg.

01 Aug 2021·Diabetes Research and Clinical PracticeQ3 · MEDICINE

Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Switzerland multicentre, prospective, observational study

Q3 · MEDICINE

Article

Author: Rudofsky, Gottfried ; Favre, Lucie ; Thomann, Robert ; Grau, Katrine ; Schultes, Bernd ; Catarig, Andrei-Mircea ; Häfliger, Susan

AIMSSURE Switzerland (NCT03631186) investigated real-world once-weekly (OW) semaglutide use in adults with type 2 diabetes (T2D).METHODSThis multicentre, prospective, observational study enrolled adults with T2D with ≥ 1 documented HbA_1c value ≤ 12 weeks before semaglutide initiation. Primary endpoint was change in HbA_1c from baseline to end of study (EOS; ~30 weeks). Secondary endpoints included changes in body weight (BW) and waist circumference (WC), and the proportion of patients achieving HbA_1c < 8.0%, <7.5% and <7.0% at EOS. Semaglutide dose at EOS was a prespecified exploratory endpoint.RESULTSOverall, 214 patients initiated semaglutide (baseline HbA_1c 7.8% [62 mmol/mol], BW 99.9 kg and WC 117.4 cm); 187 attended the EOS visit. At EOS, 175 (81.8%) were still receiving semaglutide (mean [SD] dose 0.78 [0.29] mg); in those patients, mean HbA_1c reduced by -0.8 [95% CI - 1.01;-0.68] %-points (-9 [-11;-7] mmol/mol), BW by -5.0 kg [-5.73;-4.24] and WC by -4.8 cm [-5.75;-3.79] (all p < 0.0001). At EOS, 85.9%, 76.5% and 55.9% patients achieved, respectively, HbA_1c < 8.0%, <7.5% and < 7.0%. No new safety signals were identified.CONCLUSIONSPatients with T2D in Switzerland initiating OW semaglutide experienced clinically relevant glycaemic control and BW improvements in a real-world setting, supporting semaglutide use in routine clinical practice.

News (Medical) associated with Novo Nordisk Pharma AG

26 Oct 2022

·www.biospace.com

BIOCORP and NOVO NORDISK Strengthen Their Partnership With a New Agreement on Mallya® Smart Sensor

ISSOIRE, France--(BUSINESS WIRE)-- Regulatory News: BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME) (Paris:ALCOR), a French company specialized in the design, development, and manufacturing of innovative medical devices, announces the signature of a partnership agreement with Novo Nordisk for the commercialization of Mallya, initially in Japan. This new agreement is reinforcing the partnership between Novo Nordisk and BIOCORP focused on development of the Mallya product announced in September 2021. Whereas this first development agreement was covering brands in the insulin space only, an additional therapeutic area in which Novo Nordisk has a presence has been included earlier this year. Mallya (a non-medical device in Japan) is a smart sensor that directly attaches to the Novo Nordisk FlexTouch® insulin pens. Mallya will enable patients with diabetes using FlexTouch® pens to automatically collect and record daily insulin injection data such as the number of insulin units, the date, and the time. Thanks to a mobile application linked to Mallya, patients will be able to track their injection history and follow their treatment in real-time. Mallya is compatible with all Novo Nordisk FlexTouch® insulin pens. Based on the agreement, Novo Nordisk will be commercializing Mallya in Japan from the first half of 2023. “Earlier this year, we launched the first ever smart insulin pens* in Japan (NovoPen® 6 and NovoPen Echo® Plus). However, most of our patients today in Japan use insulin with FlexTouch®. As such, we are very pleased by working with BIOCORP, which manufactures and imports Mallya, to offer digital health to even more patients” said Kasper Bødker Mejlvang, President and Representative Director of Novo Nordisk Pharma, about the agreement. * Smart insulin pen: a generic term for insulin pens which can automatically record insulin dosing data (time, quantity) and wirelessly transfer the data to mobile apps, etc. installed in user's smartphone1. “We are very proud of this commercial launch in Japan through our partner Novo Nordisk. Japan is among the leading countries in the use of diabetes management devices and monitoring devices. This is a natural and high potential market for Mallya. In addition to that launch, we’re glad to have our relationship with Novo Nordisk being reinforced on an additional therapeutic area” said Eric Dessertenne, CEO of BIOCORP. 1 David C. Klonoff, MD, Smart pens will improve insulin therapy, Journal of Diabetes Science and Technology 2018, Vol. 12(3) 551-553 ABOUT BIOCORP Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 74 employees. BIOCORP is listed on Euronext since July 2015 (FR0012788065 – ALCOR). For more information, please visit . View source version on businesswire.com: Contacts CONTACTS BIOCORP Jacques Gardette Chairman of the Board investisseurs@biocorp.fr Éric Dessertenne Chief Executive Officer Sylvaine Dessard Marketing & Communication Director rp@biocorp.fr + 33 (0)6 88 69 72 85 CONTACTS ULYSSE COMMUNICATION Bruno ARABIAN barabian@ulysse-communication.com +33 (0)6 87 88 47 26 Source: BIOCORP View this news release online at:

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