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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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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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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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Bringing glucose clamps up to speed for novel insulins

Ultra-rapid insulins in glucose clamp trials

Euglycemic glucose clamps have been widely accepted as a standard method for describing the time-action profiles of insulins for many years, and clamp results are required by regulatory authorities in the development of new insulin preparation.[1];[2]

The basic principle of a glucose clamp experiment is simple: A patient’s blood glucose (BG) is kept at a constant, predefined level after giving a test dose of insulin. This is achieved by infusing glucose intravenously at a variable rate. Close monitoring of BG levels and frequent adjustment of the glucose infusion rate (GIR) are essential for maintaining the target glucose level (or ‘clamp level’) with as little deviation as possible.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes

Posted by Oliver Klein on Jan 10, 2018 5:00:00 PM
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Targeting LDL cholesterol – How low do we need to get it? And at what price…?

People with diabetes are at a dramatically elevated risk for cardiovascular events and cardiovascular disease (CVD) is the main causes of death in people with type 2 diabetes.[1, 2] Though diabetes is mostly thought of as condition with an impaired glucose homeostasis, lowering elevated glucose levels does not appear to be an effective approach to mitigate this risk. To the contrary, aiming at very tight glucose control has sometimes been shown to be potentially harmful and to increase mortality and cardiovascular event rate.[3, 4]

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes

Posted by Oliver Klein on Jun 7, 2017 3:02:00 PM
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