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Finally breakthrough in the immunological approach to type 1 diabetes

Type 1 diabetes is a T-cell mediated autoimmune disease. For more than 40 years, researchers have tried to intervene in the autoimmune process to halt or perhaps even reverse the slow destruction of insulin producing beta cells [1]. This has proven an elusive goal, but very recently FDA granted a breakthrough therapy designation to teplizumab, an anti-CD3 monoclonal antibody  [2]. The drug modifies CD8+ T lymphocytes, which are thought to be the key effector cells that kill beta cells.

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Topics: Clinical Trials in Diabetes, Diabetes Technology

Posted by Prof. Hans de Vries on Oct 1, 2019 4:58:00 PM
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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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New PID-algorithm for automated glucose clamps

Introduction

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 at a variable rate, so that BG is "clamped" at a pre-determined target level.

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Topics: Clinical Trials in Diabetes, About Profil, Diabetes Technology

Posted by Dr. Carsten Benesch on Aug 21, 2019 5:19:00 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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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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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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