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New data on cardiovascular outcomes with dapagliflozin

Putting effects of SGLT2 inhibitors into perspective

The DECLARE-TIMI 58 trial [1] investigated the effects of treatment with dapagliflozin on cardiovascular outcomes in people with type 2 diabetes in a double blind randomized placebo controlled manner. It is the third published trial investigating cardiovascular outcomes of SGLT2 inhibitors, following EMPA-REG (for empagliflozin) [2] in 2015 and CANVAS (canagliflozin) [3] in 2017. Of these three trials, DECLARE-TIMI 58 has been the largest by a fair margin, including more than 17000 patients with type 2 diabetes who either had multiple risk factors for atherosclerotic cardiovascular disease or established cardiovascular disease.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Oliver Klein on Dec 4, 2018 5:09:00 PM
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Glucose-Responsive Insulin

The first idea [1] for a glucose-responsive insulin (GRI, commonly referred to as smart insulin) was pitched almost 40 years ago, but to our knowledge only one compound has since undergone clinical evaluation. It seems a little surprising that it takes such a long time to develop a functioning GRI because its concept is actually relatively simple: At normal glucose concentrations, small amounts of insulin are released to keep blood glucose (BG) fairly constant. In response to rising glucose concentrations, for example after a meal, more insulin is released to limit the glucose rise and to return glucose concentrations back to normal. This closed-loop insulin release should limit BG variability and because insulin is only released when it is needed, it should also reduce the risk of over- and underdosing insulin. Two key elements are needed for a GRI: (1) A component that can ‘sense’ glucose and (2) a component that can respond and control the release of insulin. The concept may be simple, suggested solutions are complex and diverse [2].

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods, Diabetes Technology

Posted by Dr. Eric Zijlstra on Nov 28, 2018 5:19:00 PM
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New strategies for the treatment of obesity and metabolic dysfunctions

Targeting the incretin/glucagon system with agonists

Figure 1: Schematic representation of the effects of multi-agonists targeting the receptors for GLP-1/Glucagon, GLP-1/GIP and GLP-1/GIP/Glucagon [28]

In Part I of our blog we reported on dual receptor agonists targeting the incretin/glucagon system to treat obesity and type 2 diabetes mellitus with high efficacy. So far, it has been recognized that the concept of combined targeting of gut hormone receptors is also working in humans [1, 2]. In Part II we will focus on the twincretins GIP and GLP-1 [3] to improve glycaemic control and the tri-agonists GLP-1/GIP/Glucagon to treat obesity, type 2 diabetes mellitus and hepatosteatosis [non-alcoholic steatohepatitis (NASH)].

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Topics: Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Nov 13, 2018 5:09:00 PM
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What news in the treatment of Type 2 diabetes was presented at EASD 2018?

The annual meeting of the European Association for the Study of Diabetes (EASD) took place this year in Berlin, Germany. The present text offers a selection of topics relevant for the field of type 2 diabetes mellitus (T2DM) discussed during that meeting.

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Topics: The Science behind Diabetes, Clinical Trial Methods, Diabetes Technology

Posted by Dr. Jorge Arrubla on Nov 6, 2018 5:09:00 PM
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Profil at 18th Annual Diabetes Technology Meeting

Profil will be present at the 18th Annual Diabetes Technology Meeting with two posters and a presentation as invited speaker. The Annual DTM will take place from November 8 to November 10, 2018, in North Bethesda, Maryland. We are looking forward to this exciting event.

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Topics: The Science behind Diabetes, Clinical Trial Methods, Diabetes Technology

Posted by Svenya Meister on Oct 29, 2018 5:15:00 PM
svenya-meister

Artificial Intelligence to Screen for Diabetic Retinopathy; The Times They Are A-Changin‘.

The far majority of clinical trials in diabetes exclude patients with active retinal disease, as interventions that lower glucose rapidly can temporarily worsen retinopathy. This was originally shown in type 1 diabetes [1] but more recently also in type 2 diabetes [2, 3]. Screening for diabetic retinopathy before inclusion in a clinical trial is relatively cumbersome, also because it often involves a separate visit to an ophthalmologist. The use of a fundus camera with offline interpretation by an ophthalmologist has gained widespread use in clinical practice, but not so much in the field of clinical trials.

In this blog I will briefly describe four recent studies on artificial intelligence approaches to automate the interpretation of retinal images. I will conclude with an outlook on how this may facilitate the screening of potential trial participants for diabetic retinopathy. But first a brief introduction to deep learning, the methodology applied in all these papers.

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Hans de Vries on Oct 23, 2018 5:18:00 PM
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New timelines for the EU Portal and implementation of the EU Clinical Trial Regulation

The EU Clinical Trial Regulation No 536/2014 (CTR), which aims to harmonise the assessment and supervision for clinical trials throughout EU Member States, was originally planned to come into application this month (October 2018). As reported earlier, the implementation of the CTR depends on the availability of a functional EU Portal, the single entry point for submitting clinical trial information in the EU, and database.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Oct 17, 2018 5:12:00 PM
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"Profil World" - The clinical diabetes research newsletter - October 2018

Dear all,

Greetings from Germany! I am happy to share with you the newest edition of "Profil World" - our newsletter filled with information about clinical research in diabetes and obesity.

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Topics: About Profil

Posted by Dr. Lars Bochmann on Oct 11, 2018 5:21:00 PM
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54th EASD Annual Meeting – Profil’s contributions to the scientific sessions

Berlin, Germany, 1-5 October 2018

Last week our team joined an exciting and busy 54th EASD Annual Meeting in Berlin. We would like to give you a brief overview about those orals and posters presenting results from clinical trials Profil had been involved in.

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Dr. Sabine Arnolds on Oct 10, 2018 4:15:43 PM
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Profil explores opportunities for artificial pancreas in type 2 diabetes

Highlighting the role of open and trans-sectoral collaboration in the advancement of artificial pancreas solutions

Profil has recently published a peer-reviewed article on the topic of “Artificial Pancreas Systems for People With Type 2 Diabetes: Conception and Design of the European CLOSE Project ” in the Journal of Diabetes Science and Technology. Profil is the organisation coordinating CLOSE. The article is authored by CLOSE industry and academic partners, representatives of the EIT Health public-private partnership management boards, and key opinion leaders in the field.

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Dr. Freimut Schliess on Oct 2, 2018 5:18:00 PM
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