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Current developments in approaches to bridging studies

Waiving Bridging studies under certain circumstances for biosimilar applications?

A bridging study is a study performed in a new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen that will allow extrapolation of foreign clinical data to the population in the new region [1]. However, in most cases bridging studies between an original product versus a so called foreign reference or a local reference product generate costs without providing any notable benefit for the specific patient, nor notable scientific output. 

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Diabetes Technology

Posted by Dr. Grit Andersen on Sep 17, 2019 5:25:00 PM
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iPDM Goes Europe: tangible impact on diabetes patients and care

Treatment inertia calls for an integrated personalized diabetes management: iPDM

Diabetes represents a huge and multidimensional challenge for European societes. It not only leads to premature ageing and frailty but also promotes chronic conditions like cardiovascular disease, blindness, dementia and even cancer. Despite the availability of numerous treatment options treatment inertia is still a common problem: many patents still fail to reach their treatment goals. According to the UK National Diabetes Audit data 2016- 2017, only 30% of people with type 1 diabetes and 67% of people with type 2 diabetes achieved a HbA1c target of not more than 58 mmol/l (7.5%).

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

Posted by Prof. Dr. Freimut Schliess on Sep 3, 2019 5:17:00 PM
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Dual-hormone artificial pancreas systems

Dual-hormone artificial pancreas systems use insulin and glucagon to control glucose in patients with diabetes - a dream is about to come true

Insulin-only closed-loop AP systems hold promise for reducing the burden of diabetes self-management, but there is still potential for improvement regarding both hypoglycaemia and hyperglycaemia. A dual-hormone AP system achieves closed–loop glycaemic control by subcutaneous infusion of insulin and of glucagon in response to glucose values detected by a continuous glucose monitoring device mimicking the physiological pattern of insulin and glucagon secretion of a healthy pancreas more closely than an insulin infusion-only system.

To reverse the insulin action when blood glucose shows a tendency to fall, glucagon is given as mini-boluses to prevent and to treat any imminent hypoglycemia [1]. Glucagon leads to a rapid conversion of hepatic glycogen (the stored form of glucose) into glucose which is then released into the bloodstream. The comprehensive technology of control algorithms and hardware and the development of long-term stable glucagon formulations have so far provided some development challenges.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Jul 16, 2019 5:03:00 PM
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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
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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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Artificial pancreas in type 2 diabetes

Close the loop in diabetes care

Artificial pancreas systems are medical products that use algorithms informed by continuous glucose monitoring (CGM) data of a given patient, thereby regulating the rates of a continuous subcutaneous insulin infusion through an insulin pump. In this way, artificial pancreas systems are taking over control of the patient’s blood glucose levels.

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

Posted by Prof. Dr. Freimut Schliess on Feb 19, 2019 5:21:00 PM
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Digital Diabetes: better trials, better drugs, better care

Background

Diabetes is a multidimensional challenge for global societies. Despite the availability of drugs and technology many patients don’t reach their treatment goals.  According to the UK National Diabetes Audit data 2016-2017 only 30% of people with type 1 diabetes and 67% of people with type 2 diabetes achieved a HbA1c target of 58 mmol/l (7.5%). When considering also blood pressure and cholesterol targets, these figures dropped to 19% and 41% respectively.

The good news is that diabetes leaves a huge room for Innovation. Risk factors are modifyable, type 2 diabetes is potentially reversible and the role of the patient’s self-management is of outstanding importance. Diabetes could serve as a paradigm for cracking down treatment inertia and narrowing the gap between the efficacy of investigational medicinal products seen in well controlled clinical trials and the lower than expected effectiveness of drugs observed in real-world chronic care (E2E gap) [1].

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

Posted by Prof. Dr. Freimut Schliess on Jan 29, 2019 5:13:00 PM
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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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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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