A non-interventional cross-sectional study to capture the prevalence of cardiovascular disease in patients with type 2 diabetes - an international observation

开始日期2019-01-28

申办/合作机构

Novo Nordisk Pharma Ltd.

JPRN-jRCT1080224506

/ CompletedN/A

A non-interventional cross-sectional study to capture the prevalence of cardiovascular disease in patients with type 2 diabetes - an international observation

开始日期2019-01-28

申办/合作机构

Novo Nordisk Pharma Ltd.

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项与 Novo Nordisk Pharma Ltd. 相关的文献（医药）

2025-04-01·Obesity Research & Clinical Practice

Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial

Article

作者: Overvad, Maria ; Ogawa, Wataru ; Nishida, Tomoyuki ; Kadowaki, Takashi ; Yamauchi, Toshimasa ; Tobe, Kazuyuki

OBJECTIVEA post hoc analysis of a subset of participants with visceral fat area (VFA) measurements in the STEP 6 trial was conducted to examine both the correlation between VFA and clinical parameters and the effect of semaglutide on VFA in key subgroups.METHODSParticipants were Japanese adults aged ≥ 20 years with obesity disease, randomized to once-weekly subcutaneous semaglutide 2.4 mg, semaglutide 1.7 mg, or placebo, plus lifestyle recommendations, for 68 weeks. Correlation between baseline VFA (and change in VFA from baseline to week 68) and clinical parameters (body weight, body mass index [BMI], waist circumference, hepatic parameters, glycated hemoglobin, blood pressure, lipids, high-sensitivity C-reactive protein, and plasminogen activator inhibitor-1 [PAI-1]) was evaluated. Percentage change in VFA between semaglutide and placebo was compared across subgroups.RESULTSAmong 180 participants (semaglutide 2.4 mg, n = 89; semaglutide 1.7 mg, n = 46; placebo, n = 45), mean VFA was 170.0 cm² across subgroups. A positive correlation (Pearson's correlation coefficient [r] ≥0.3) was observed between baseline VFA and body weight (r = 0.415), BMI (r = 0.374), and both JASSO and WHO criterion waist circumference (r = 0.458 and r = 0.555). Correlation between changes in VFA and body weight, waist circumference, high-density and very low-density lipoprotein cholesterol, triglycerides, PAI-1, aspartate aminotransferase, and alanine transaminase were observed in ≥ 1 treatment arm. Semaglutide 2.4 mg and 1.7 mg reduced VFA compared with placebo in all subgroups.CONCLUSIONSVFA partially correlated with clinical parameters in Japanese adults with obesity disease. Subcutaneous semaglutide was an efficacious treatment option for the reduction of VFA, regardless of clinical characteristics.TRIAL REGISTRY NAMECT.gov TRIAL REGISTRATION IDENTIFICATION NUMBER: NCT03811574.

2025-04-01·Diabetologia

Once-weekly IcoSema versus once-weekly semaglutide in adults with type 2 diabetes: the COMBINE 2 randomised clinical trial

Article

作者: Yabe, Daisuke ; Jódar, Esteban ; Riveline, Jean-Pierre ; Chen, Liming ; Nishida, Tomoyuki ; Réa, Rosângela ; Lingvay, Ildiko ; Benamar, Malik ; Fu, Ariel ; Zueger, Thomas

AbstractAims/hypothesisCOMBINE 2 assessed the efficacy and safety of once-weekly IcoSema (a combination therapy of basal insulin icodec and semaglutide) vs once-weekly semaglutide (a glucagon-like peptide-1 analogue) 1.0 mg in individuals with type 2 diabetes inadequately managed with GLP-1 receptor agonist (GLP-1 RA) therapy, with or without additional oral glucose-lowering medications.MethodsThis 52 week, randomised, multicentre, open-label, parallel group, Phase IIIa trial was conducted across 121 sites in 13 countries/regions. Adults with type 2 diabetes (HbA1c 53.0–85.8 mmol/mol [7.0–10.0%]) receiving GLP-1 RA therapy with or without additional oral glucose-lowering medications were randomly assigned 1:1 to once-weekly IcoSema or once-weekly semaglutide 1.0 mg. The primary endpoint was change in HbA1c from baseline to week 52; superiority of IcoSema to semaglutide 1.0 mg was assessed. Secondary endpoints included change in fasting plasma glucose and body weight (baseline to week 52), and combined clinically significant (level 2; <3.0 mmol/l) or severe (level 3; associated with severe cognitive impairment requiring external assistance for recovery) hypoglycaemia (baseline to week 57).ResultsOverall, 683 participants were randomised using a Randomisation and Trial Supply Management system to IcoSema (n=342) or semaglutide 1.0 mg (n=341). Mean ± SD baseline characteristics were as follows: HbA1c 64.0±8.2 mmol/mol (8.0±0.7%); diabetes duration 12.6±6.9 years; and BMI 31.1±4.7 kg/m2. From baseline to week 52, mean change in HbA1c was −14.7 mmol/mol (−1.35%-points) in the IcoSema group and −9.88 mmol/mol (−0.90%-points) in the semaglutide group; the estimated treatment difference (ETD) was –4.85 (95% CI −6.13, −3.57) mmol/mol (−0.44 [95% CI −0.56, −0.33]%-points), confirming superiority of IcoSema to semaglutide (p<0.0001). The estimated mean change in fasting plasma glucose from baseline to week 52 was statistically significantly reduced with IcoSema vs semaglutide (−2.48 mmol/l vs −1.43 mmol/l, respectively; ETD −1.05 [95% CI −1.36, −0.75] mmol; p<0.0001). Mean change in body weight from baseline to week 52 was statistically significantly different between groups: +0.84 kg for IcoSema vs −3.70 kg for semaglutide (ETD 4.54 kg [95% CI 3.84, 5.23]; p<0.0001). There was no statistically significant difference in the rate of combined clinically significant or severe hypoglycaemia between IcoSema and semaglutide (0.042 vs 0.036 episodes per person-year of exposure; estimated rate ratio 1.20 [95% CI 0.53, 2.69]; p=0.66). The proportion of participants experiencing gastrointestinal adverse events was similar between treatment groups (IcoSema 31.4%; semaglutide 34.4%).Conclusions/interpretationIn people living with type 2 diabetes inadequately managed with GLP-1 RA therapy, with or without additional oral glucose-lowering medications, switching to once-weekly IcoSema in comparison with once-weekly semaglutide 1.0 mg demonstrated superiority in HbA1c reduction, similar rates of clinically significant or severe hypoglycaemia, and similar frequency of gastrointestinal adverse events. However, weight change from baseline to week 52 was statistically significantly in favour of semaglutide 1.0 mg.Trial registrationClinicalTrials.gov NCT05259033FundingThis trial was funded by Novo NordiskGraphical Abstract

2025-04-01·Pituitary

Prevalence and risk of complications in untreated patients with adult growth hormone deficiency

Article

作者: Tsuboi, Satoshi ; Fukuoka, Hidenori ; Fujio, Shingo ; Endo, Takaaki

AbstractPurposeAdult growth hormone deficiency (AGHD) increases the prevalence of complications, including metabolic disorder, leading to increased cardiovascular mortality from cardiovascular diseases. However, no large database studies have evaluated AGHD patients without GH replacement therapy (GHRT). We investigated the prevalence of AGHD-related complications in patients without GHRT.MethodsPatients with AGHD and associated complications were identified from the Medical Data Vision claims database using Japanese local disease codes mapped to ICD-10 codes. The prevalence of AGHD-related complications in 2020 was estimated to compare with the prevalence in the Japanese general population in the latest available year 2020. Risk factors for complications were evaluated by Kaplan-Meier curves and a Cox proportional hazard model.ResultsWe identified 8,809 untreated patients with AGHD from April 2008 to September 2022, including 3,430 in 2020. In 2020, the prevalence of complications was higher in the AGHD population adjusted for sex and age than in the Japanese general population, e.g., diabetes mellitus, 9.3% vs. 3.6%; osteoporosis, 4.8% vs. 1.3%; and dyslipidemia, 22.0% vs. 3.9%. Age was a significant risk factor for most complications, and female sex for osteoporosis. Diabetes mellitus was a significant risk factor for dyslipidemia, ischemic heart disease, cerebrovascular disease, and all-cause death.ConclusionUntreated patients with AGHD have a higher prevalence of metabolic complications than the general population despite no difference in their related risk factors. Given the low use of GHRT in this study, comprehensive treatment approaches that include GHRT need to be considered to alleviate the risk of complications.

项与 Novo Nordisk Pharma Ltd. 相关的新闻（医药）

2023-03-28

·PRNewswire

Health2Sync Partners with Novo Nordisk and Biocorp in Japan to Integrate Mallya®︎ Cap

Bringing Fully Digitized Experience for Diabetes Patients on Insulin and Adding Another Data Point to Japan's Personal Health Record Initiative TAIPEI, March 27, 2023 /PRNewswire/ -- Health2Sync (Taipei, Taiwan and Tokyo, Japan) announces today that its latest version of the Health2Sync App integrates insulin data from Mallya® Cap, the connected device dedicated to insulin pens developed by Biocorp and marketed in Japan by Novo Nordisk. This partnership realizes the first data integration of its kind in the world and is expected to help patients on insulin treatment manage their health by capturing multiple data points, including insulin injection logs. The population of diabetes and pre-diabetes exceeds 20 million in Japan[1]. Thanks to the advances in insulin and non-insulin drugs during the past two decades, the combined use of those drugs in Japan increased, and the glycemic control leveled off after 2014 in patients with type 2 diabetes[2]. However, according to a 2017 study, 44% of Japanese diabetes patients still reported omission or non-adherence to insulin, a greater value than that reported in other countries[3]. Patients treated with insulin need to measure their blood glucose multiple times a week and inject insulin accordingly, and the large amount of data makes it difficult and burdensome for patients to accurately record the time and amount of each injection and make proper adjustments based on clinicians' guidance. Mallya® is a non-medical smart sensor that attaches directly to the FlexTouch® insulin pen, saving time and effort from manually inputting or recording injection data. After attaching the Mallya® cap to a FlexTouch® pen, the smart cap enables automatic data collection and sends the injection dosage, date, and time to the Health2Sync App wirelessly in real-time. The synchronized data can be analyzed with diet and blood glucose levels by the Health2Sync App, providing further analyses and a more accurate understanding of personal glucose management and lifestyle adjustments. "With the Health2Sync solution, we are able to tap into markets like Japan, where the use of connected devices and medicine are highly advanced", said Eric Dessertenne, CEO of Biocorp. "We also believe that such integration with automatic analyses will empower patients to make timely personal adjustments." "Launching the Mallya®︎ cap demonstrates the further value we hope to bring to patients on insulin treatment," said Bruno Lacombe, the Vice President of Diabetes Business Unit at Novo Nordisk Pharma Ltd. "In Japan, efficient dosage recording and data visualization are critical parts to the diabetes management." Dr. Yasutaka Maeda, Director of Minami Diabetes Clinical Research Center said, "With the Mallya® Cap, it is very easy and efficient for patients to comply with the insulin treatment as the details of insulin injections are automatically transferred to the Health2Sync app. This enables healthcare providers to make evidence-based treatment recommendations." Dr. Atsuhito Tone, Deputy Director of Internal Medicine and Diabetes Center of Okayama Saiseikai General Hospital said, "From the clinician's perspective, the Mallya®︎ Cap and Health2Sync solution captures insulin dose and glucose trends in a single platform, helping healthcare providers with better decision making., Integrating medical and health information with both public and private PHR providers is expected as part of PHR initiative we are witnessing in Japan." "By integrating the Mallya®︎ Cap, we are very excited about improving accuracy and expanding the data categories to be captured," said Ed Deng, CEO of Health2Sync. "Following the Ministry of Economy, Trade and Industry's (METI) effort in 2022 to drive PHR[4], we will continue to work with various stakeholders in Japan to provide integrated solutions and encourage patients to manage their health through digital tools better." The Mallya®︎ data integration is now available to the 350,000 Health2Sync users in Japan. Health2Sync plans to deploy comprehensive digital insulin management experiences to other countries this year. [1] [2] [3] '%20lifestyles [4] SOURCE Health2Sync

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