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Is there a ‘true’ insulin time action profile?

The impact of different study populations in glucose clamp studies

Over the last decade, the euglycemic clamp technique has evolved to the reference method for assessing time action profiles of insulins, and regulatory agencies require glucose clamp trials as part of the clinical development of novel and biosimilar insulin products [1, 2]. Of course the experimental set-up of glucose clamp trials can vary, depending for example on whether a long-acting or a rapid-acting insulin is tested. However, one of the most important decisions when planning glucose clamp trials is the choice of a suitable study population. The choice is between patients with type 1 diabetes, type 2 diabetes, or healthy people. Indeed, healthy volunteers can be the preferable option. Each of these groups comes with their own specific advantages and disadvantages.

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Oliver Klein on Jun 18, 2019 5:21:00 PM
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Applications of iontophoresis in studies investigating microvasculature

People suffering from Diabetes Mellitus can develop both macrovascular and microvascular complications. Retinopathy, nephropathy and neuropathy are the main microvascular complications occurring in Diabetes Mellitus. Mechanisms include structural and functional alterations resulting from chronically elevated glucose concentrations. Therefore, assessment of the microvasculature is important for studies investigating new treatment modalities in diabetes.

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

Posted by Dr. Jorge Arrubla on Jun 4, 2019 5:21:00 PM
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The ideal basal insulin?

Long-acting insulins have been developed for patients with diabetes to provide a basal insulin cover during the day and night. The first slow-release formulations used protamine and/or zinc to achieve a duration of action up to 16 hours. Since 2000 insulin analogues with different mechanisms of protraction are available and achieve a predictable glucose lowering effect with one daily injection. Currently, ultra-long acting insulin analogues are available that have a duration of action beyond 24 hours. This prolonged duration of action reduces day-to-day variability and offers daily dosing flexibility [1]. What further improvements in basal insulin therapy can be expected in the future and what exactly does the ideal basal insulin look like?

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Topics: Treating Diabetes

Posted by Dr. Eric Zijlstra on May 21, 2019 4:57:00 PM
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"Profil World" - The clinical diabetes research newsletter - May 2019

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 Svenya Meister on May 6, 2019 4:55:00 PM
svenya-meister

Profil is co-founder of KomIT

KomIT - the new Center of Competence for Innovative Diabetes Therapy

Profil is co-founder of a new consortium of partners from industry and academia focusing on the development and clinical implementation of new diabetes therapies. 
 

During the next three years KomIT, the new Center of Competence for Innovative Diabetes Therapy, will be established at the German Diabetes Center (DDZ) based on a total funding of about 3.5 Mio Euro. This funding is jointly provided by the Land North Rhine-Westphalia and the European Union. KomIT is coordinated by Professor Michael Roden, the scientific Managing Director of the DDZ.

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

Posted by Svenya Meister on Apr 30, 2019 5:09:00 PM
svenya-meister

NAFLD/NASH: a ticking bomb not yet defused

Unmet medical needs in NAFLD and NASH

NAFLD (non-alcoholic fatty liver disease) comprises a spectrum of conditions starting with adiposity of the liver (fatty liver, steatosis hepatis) and ranging up to NASH (non-alcoholic steatohepatitis). Currently about 30% of the general population and 60-80% of people with type 2 diabetes are considered to be affected by NAFLD [1].

Premature mortality from NAFLD comes from the development of diabetes and cardiovascular disease and progression of the fatty liver to the more irreversible and aggressive NASH which again predisposes for incident liver cirrhosis and hepatocellular carcinoma [2]. Despite the potentially disastrous outcome of NAFLD and an increasingly rich knowledge concerning the underlying molecular pathogenesis no rational drugs and therapies specifically dedicated to the treatment of NAFLD are available yet. 

In this blog we first provide a brief overview on the key pathogenetic drivers in NAFLD. Then we highlight the inherent opportunities and challenges for developers of lifestyle interventions and drugs tackling NAFLD. And last but not least we discuss some key issues related to the design and implementation of clinical trials in NAFLD and NASH.

If you want to learn more on Profil’s general perception of the liver’s role in health and disease you are invited to read our „Liver first? The liver in diabetes and cardiovascular disease“ series of blogs (part I, part II, part III).

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

Posted by Prof. Dr. Freimut Schliess on Apr 25, 2019 5:25:00 PM
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Profil joined iPDM-GO

Personalized Diabetes Management in Europe

In the year 2018 Profil joined the team creating the iPDM-GO (integrated Personalized Diabetes Management Goes Europe) consortium for implementing integrated Personalized Diabetes Management in Europe. Following a thorough and competitive evaluation the iPDM-GO project at the beginning of 2019 became part of the Innovation portfolio curated by EIT Health. EIT Health is a public-private knowledge and innovation community (KIC) of best-in-class health innovators backed by the European Union. The KICs Innovation ecosystem enables a collaborative multi-stakeholder approach to implementing a more effective diabetes management in Europe.

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

Posted by Prof. Dr. Freimut Schliess on Apr 16, 2019 5:07:00 PM
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Free webinar on Diagnosis of NAFLD

Profil continues the successful series of scientific webinars. On May 8th, 2019 we will air our free webinar on Diagnosis of NAFLD. The session is presented by Prof. Dr. Andreas Erhardt, Chief Physician at Petrus Hospital in Wuppertal, Germany. 

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Topics: About Profil

Posted by Svenya Meister on Apr 9, 2019 5:17:00 PM
svenya-meister

Are soccer players with dark skin tone more likely to receive red cards?

And why does this matter in drug development?

Statistical analytical methods are often taken for granted. In a recent crowdsourcing data analysis project, Nosek and co-workers found 29 research teams willing to analyze the same dataset [1]. The results varied from positive to neutral. How is this possible and what are the consequences? 

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Topics: Clinical Trial Methods

Posted by Prof. Hans de Vries on Mar 12, 2019 5:11:00 PM
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"Profil World" - The clinical diabetes research newsletter - February 2019

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 Svenya Meister on Feb 27, 2019 5:24:00 PM
svenya-meister

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