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Glucose-Infusion-Rate based categorization of glucose clamps

The glucose clamp is a method for the determination of pharmacokinetic and pharmacodynamic (PK/PD) effects of anti-diabetic drugs (e.g. insulin) where the blood glucose (BG) concentration lowering effect is antagonized by variable glucose infusion rates (GIR).

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Topics: Clinical Trials in Diabetes, Diabetes Technology

Posted by Mareike Kuhlenkötter on Jan 15, 2019 5:03:00 PM

Update on Brexit: Impact on future and current clinical trials in Germany

As the withdrawal of the United Kingdom from the European Union is coming closer, the Competent Authority in Germany (BfArM) recently published their procedures for the period thereafter.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Jan 8, 2019 5:05:00 PM
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Pramlintide as adjunct therapy for the treatment of type 1 diabetes

Where are we today?

Insulin treatment for type 1 diabetes mellitus (T1D) has improved over the past decades due to advances in insulin formulations and administration techniques. Nevertheless, optimal glucose control and reaching HbA1c goals remain challenging for many patients. Consequently, the risk of subsequent micro- and macrovascular complications remains high and life expectancy is still reduced in this patient group so that there is an obvious need for improvement of current therapies or the development of new, additional treatments [1]. So what else can be done?

 

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Susanne Famulla on Dec 19, 2018 5:12:00 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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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 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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Work stress is the new smoking

According to the WHO, about 31% of all deaths worldwide (17.7 million deaths per year) [1] are attributable to cardiovascular disease (CVD), making CVDs the number 1 cause of death globally. Known risk factors for the development of CVD, among others, are smoking, high blood pressure or the lack of physical activity. Especially the latter has been discussed in the recent years and it became known that long hours of sitting [2] may increase your risk of CVD and diabetes (and may apparently even increase mortality, in the case of binge watching [3]). While numerous risk factors for CVD are known and several recommendations and guidelines on how to handle them exist, the prognostic role of what may possibly be one of the most common and important factors on cardiovascular health nowadays has not yet been formally assessed: stress at work.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Theresa Herbrand on Sep 25, 2018 5:12:00 PM
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Even moderate overweight increases the risk for cardiovascular disease, recent study says

A substantial amount of studies in the last decade have determined the detrimental effects of overweight and obesity on the risk of myocardial infarction, stroke, cancer, and overall mortality. Nonetheless, there is also evidence in favour of the so-called “obesity-paradox” which states that overweight - or even obesity - exerts a protective role or has no impact on the incidence of cardiovascular disease (CVD) and overall mortality, because of increased cardiovascular mortality in the lowest BMI strata (J-curve).

In March 2018, a study was published by researchers from the University of Glasgow, challenging the obesity-paradox and heating up the debate of this much-discussed topic [1].

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Topics: Clinical Trials in Diabetes, Treating Diabetes, Clinical trials in Obesity

Posted by Dr. Daniela Lamers on Aug 7, 2018 5:09:00 PM
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Clamp studies with ultra-long-acting insulins – New challenges for an old procedure

The euglycemic clamp technique has been used as a standard method for assessing time action profiles of insulins for decades. In recent years, new challenges have emerged for investigators performing glucose clamp trials. These are driven by two opposing trends in the development of novel insulins: On the one hand, drug developers are formulating insulin products with a very rapid onset of action and a short duration of action – often referred to as “ultra-rapid insulins” [1,2]. On the other hand, novel basal insulins are being developed with an “ultra-long” duration of action with flatter activity profiles than previously available products [3,4,5].

 

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

Posted by Oliver Klein on Jul 24, 2018 5:11:00 PM
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Gut Microbiota and Type 2 Diabetes

For many years, microbes, e.g. bacteria, fungi, viruses and other microorganisms, have solely been associated with diseases and unhygienic conditions. In response, mankind has spared little effort to eradicate these organisms, be it in everyday life through ubiquitously available disinfectants or in a medical setting, e.g. through antibiotics or antifungal medication. While there are places where a germ-free environment is vital, e.g. an operation room, one needs to differentiate between spaces in which microorganisms physiologically should not exist (e.g. in our bloodstream) or spaces in which they should flourish (e.g. the colon).

Bearing this in mind, in recent years, researchers have found that the microorganisms living on and in our body (i.e. any surface connected to the outside world, e.g. skin, nasal and oral cavities, our gastrointestinal tract et cetera), our microbiota, are, in fact, not harmful to us. On the contrary, they may contribute to our health and well-being and protect us against actual pathogens (by forming a so-called “colonization resistance" [1]). In addition, research has revealed the complexity and diversity of our gut microbiota which may be in part responsible for the development of certain diseases including obesity and type 2 diabetes [2].

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Topics: Clinical Trials in Diabetes, Treating Diabetes, Diabetes Technology

Posted by Dr. Theresa Herbrand on Jul 4, 2018 5:16:00 PM
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