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Running clinical trials at Profil during pandemic times

Impact of COVID-19 on clinical trials

In December 2019, China was affected by several cases of what was considered a fatal viral pneumonia (1). The numbers of affected patients were exponentially increasing and on January 9th 2020 Chinese authorities made a preliminary determination of a novel coronavirus which became known as SARS-CoV-2 or COVID-19 (1). Not long after, on January 30th 2020 the World Health Organisation (WHO) declared the COVID-19 outbreak as a global emergency (2). This was just the beginning of a pandemic that has come to challenge all what we thought to be normal and forced us to adapt to a new reality - a new lifestyle. This new reality has also affected clinical research as resources given to human trials were diverted towards the pandemic response resulting in the termination, suspension or withdrawal of more than 1700 clinical trials worldwide (3). In addition, most of the ongoing studies have undergone substantial modifications in order to address the safety of participants, staff and investigators (4) and here at Profil we are proud to be at the forefront of finding answers to these new challenges.

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Topics: Clinical Trials in Diabetes, About Profil

Posted by Javiera Villagra on Jan 7, 2021 4:00:00 PM
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Profil World - The clinical diabetes research newsletter - December 2020

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 Dec 17, 2020 10:19:00 AM
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β3-adrenoceptor agonist Mirabegron – a candidate anti-obesity drug?

The β3‐adrenoceptor (β3-AR) was initially an attractive target for several pharmaceutical companies due to its high expression in rodent adipose tissue, where its activation resulted in decreased adiposity and improved metabolic outcomes in animal models of obesity and type 2 diabetes. Despite the expression of β3-AR in human brown and white adipocytes, urinary bladder and potentially other tissues [1, 2, 3], the translation of rodent studies to humans was cumbersome as several drugs acting on the β3-AR failed in achieving weight loss targets.

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Topics: Treating Diabetes, Clinical trials in Obesity

Posted by Dr. Daniela Lamers on Dec 1, 2020 4:00:00 PM
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Once-weekly basal insulin analogue in clinical development

Once-weekly basal insulin icodec treatment may offer more convenience in people with type 2
diabetes and may improve outcomes.

Molecular and biological properties of once-weekly insulin icodec and promising phase 1 and 2 data
were presented at American Diabetes Association’s 80th Scientific Sessions and 56th European
Association for the Study of Diabetes (EASD) Annual Meeting 2020.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Nov 17, 2020 4:00:00 PM
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Glycaemic control in type 1 diabetes – effects of diabetes technology and socioeconomic status

The landmark trials DCCT/EDIC trials show how important good glycaemic control is for the prevention of late complications in type 1 diabetes (T1D). According to the American Diabetes Association (ADA) an HbA1c target value of less than 7% should be targeted throughout all age groups to reduce the risk of late complications unless safety issues for individual patients or patients groups indicate higher HbA1c goals. However, most patients have difficulties to reach this target value despite improvements in diabetes therapy options during the last years. Especially the age group between 15 and 25 years have significantly higher HbA1c levels as analysis of data of various countries show [1]. The analysis of an US database, the so-called T1D Exchange registry which contains data of more than 35000 patients with T1D, indicate that glycaemic control in adolescents and young adults seems to get even worse in the past years as from 2012 until 2018 the average HbA1c has increased, particularly in the younger age groups [2].

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Topics: Treating Diabetes, Diabetes Technology

Posted by Dr. Susanne Famulla on Nov 4, 2020 4:00:00 PM
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Profil World - The clinical diabetes research newsletter - October 2020

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 13, 2020 4:30:00 PM
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Free Online Seminar: Profil - the leading CRO for metabolic research

Profil continues the successful series of scientific online seminars. On October 7th, 2020 at 4 PM CEST we will air our free online seminar. The session is presented by Dr. Lars Bochmann, Director Marketing and Business Development at Profil. 

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Topics: About Profil

Posted by Dr. Lars Bochmann on Sep 21, 2020 4:00:00 PM
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Profil starts in-house production of tubing sets for ClampArt®, reinforcing the quality of world-class glucose clamp trials

The euglycemic, hyperinsulinemic glucose clamp is the gold standard for the determination of pharmacokinetic and pharmacodynamic (PK/PD) effects of (new) anti-diabetic drugs, in particular insulins. In a typical glucose clamp experiment, a drug-induced decline in blood glucose (BG) concentrations is prevented by infusing glucose with a variable glucose infusion rates (GIR) to keep blood glucose concentrations (BG) as closely as possible to a pre-defined target level. 

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Topics: Clinical Trial Methods, Diabetes Technology

Posted by Dr. Carsten Benesch on Sep 8, 2020 4:02:00 PM
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The rollercoaster life of inhaled insulin

From Nektar’s award-winning technology to its later commercial failure as Pfizer’s Exubera®. Followed by new hopes for Mannkind’s Afrezza® that suffered more commercial disappointment [1,2,3,4]. The life of pulmonary delivery of insulin (inhaled insulin) has been a thrilling rollercoaster ride. Experts have openly asked whether inhaled insulin has come to the end of its ride or whether there is still a place for inhaled insulin in the future [5]. In this blog article on inhaled insulin, we’ll have a look at what the future may look like and discuss the latest advances with a novel inhaled insulin.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Eric Zijlstra on Aug 4, 2020 4:15:00 PM
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Heart failure: SGLT2 inhibitors moving beyond diabetes

Sodium/glucose cotransporter 2 (SGLT2) inhibitors have gained momentum in the last few years due to their therapeutic effectivity and the potential to reduce cardiovascular (CV) risks in type 2 diabetes [1, 2, 3].

The mechanisms involved in the improved risk profile observed seem to be a combination of several factors, including blood pressure reduction, increased sodium excretion, weight reduction and improved heart function [4].

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Jorge Arrubla on Jul 14, 2020 4:15:00 PM
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