Looking beyond blood glucose - the islet of Langerhans

A pathophysiological approach in the treatment of patients with diabetes mellitus 

Like any drug development process, developing novel anti-diabetic drugs is a difficult endeavour. This holds especially true in the midst of the wave of novel drugs and drug classes that we have seen entering the market over the last years. To be successful in this area, it is crucial to think beyond blood glucose levels when developing novel compounds.

Insulin resistance, alpha-, and beta cell dysfunction characterize the pathophysiological triade in the development of type 2 diabetes mellitus. Investigation of drug effects and/or drug interactions with these components in the development and progression of diabetes mellitus can provide more rationality for the selection of drugs or drug combinations in the treatment of the disease. To address the importance of islets of langerhans in diabetes and their complicated balance, this text deals with the islets of Langerhans and the alpha- and beta cell function in diabetes. It then shifts focus to the pharmacological intervention and methods to study the cells' function to enable developers choose the right tools for their clinical trials in this field.

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Topics: The Science behind Diabetes, Treating Diabetes

Posted by Prof. Dr. Thomas Forst on Jul 4, 2017 5:07:00 PM

Considering the Complexity of Food-Drug Interactions for drug development


While drug-drug interactions are widely acknowledged and taken into account in clinical settings in patient management, the effects of food-drug interactions are not as well-known even though the effects may be just as harmful. For patients as well as medical doctors, it is important to consider various factors that can alternate the efficacy of a drug. During drug development, the pharmacokinetic and pharmacodynamic characteristics of a drug are investigated. The ideal therapeutic window of a drug, i.e. the range in which the drug is effective without being harmful, would have a minimum toxic concentration, which is multiple times the minimum effective concentration, offering a wide therapeutic window, free of side effects. This therapeutic window, or therapeutic index, can be quantified using the following formula:                                                         

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Topics: Clinical Trials in Diabetes

Posted by Theresa Herbrand on Jun 28, 2017 5:02:00 PM

Smart Insulin Patches or Glucose-Responsive Insulin Delivery Systems

A promising approach that could be a game-changer for patients with diabetes.

Since its discovery and isolation, exogenous insulin has resulted dramatically change in the prognosis for patients with diabetes. Nowadays, novel insulin analogues have improved pharmacokinetic profiles mirroring endogenous basal and prandial insulin secretion more closely. However, despite advances in insulin formulations and in closed loop systems combined with advanced continuous glucose-monitoring systems and external insulin infusion pumps, glucose control still remains a challenge. Patients with diabetes do not achieve their glycaemic targets and hypoglycaemia continues to be the major hurdle for intensification of insulin therapy.

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Topics: The Science behind Diabetes

Posted by Dr. Ulrike Hövelmann on Jun 21, 2017 4:54:00 PM

A different design of Glucose Clamps: Fixed Rate of Blood Glucose Change rather than Fixed Blood Glucose Levels

Glucose Clamps

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.

Thus, the glucose clamp is designed as a closed-loop system where BG is measured frequently and the changes in BG and deviation of BG from the target level are the major factors for determining glucose infusion rates.

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Topics: Clinical Trials in Diabetes, About Profil Germany

Posted by Dr. Carsten Benesch on Jun 13, 2017 4:27:00 PM

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

Don't miss ADA 2017 President's Oral Session

Profil will be all over the conference

Just one more week to ADA 2017 Scientific Sessions! This sessions will be packed with relevant presentations and posters as usual. However this year ADA is even more special for Profil. We will have our very own booth at the conference (booth #115) and we are proud to share with you that our expert, Dr. Leona Plum- Mörschel, will be presenting at the ADA President's Oral Session on June 13.

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Topics: Events

Posted by Tatiana Dicenzo on Jun 1, 2017 5:00:00 PM

Will noninvasive glucose monitoring end in tears?

Controlling blood glucose levels within a normal range is the objective of diabetes management and will help to prevent long-term complications such as damages to the eye, kidneys and the nervous system and may also reduce the risk of cardiovascular events such as a heart attack or stroke. To achieve good glucose control in a safe manner without hypo- or hyperglycaemia, many patients with diabetes need to check their blood glucose level several times per day before making a treatment decision. The standard self-measurement requires patients to perform a finger prick with a lancet needle and measure the glucose content of the obtained capillary blood drop with a handheld glucose meter system. A patient diagnosed with diabetes type 1 at age 20 may easily have to perform more than 75.000 of these painful finger pricks during a lifetime, each causing a small injury to the skin.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes

Posted by Dr. Eric Zijlstra on May 24, 2017 1:59:00 PM

Meet us at the MedTech Summit 2017


Focusing on Medical Technology, Mobile Health, Innovation Management, Regulatory Affairs, Diagnostics, Strategic Partnerships and Digitalization, the MedTech Summit 2017 congress will take place on June  21 and 22 in Nurnberg, Germany. 

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Topics: Events

Posted by Tatiana Dicenzo on May 16, 2017 5:21:00 PM

First in Human (FIH) Trials: New draft guideline for Risk Mitigation

To provide best achievable clinical safety is always a challenge in first in human trials. Starting with the decision to proceed from preclinical research to the clinical development of a new drug researchers are confronted with many challenges including creating an appropriate study design, preparing the regulatory documents, conducting the clinical trial and, finally, drawing the right conclusions from the data.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on May 16, 2017 3:40:00 PM

New Study about Sugar vs. Calorie-free Sweeteners

No influence of calorie-free drinks on total daily energy intake compared to sugar-sweetened drinks, recent study says

Worldwide, the incidence of obesity is increasing dramatically having more than doubled since 1980 [1]. Because obesity is associated with an array of metabolic pathologies, including cardiovascular disease, type 2 diabetes, musculoskeletal disorders, and even some cancers, identifying strategies that help regulate body weight is imperative.

Substituting nutritive sweeteners by non-nutritive sweeteners (NNS), including artificial and natural NNS, may have potential in facilitating weight control [2-4]. By preserving palatability despite having fewer calories than sugar, NNS could help to lower the energy density of beverages and foods, resulting in a lower total energy intake. However, recurring arguments indicate that NNS increase the appetite for sweet foods, promote overeating, and may even lead to weight gain[5-7]. In light of that, numerous studies in the past two decades have been performed to address these issues, with the overall question remaining: Do NNS help to reduce body weight?

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Topics: The Science behind Diabetes, Treating Diabetes

Posted by Dr. Daniela Lamers on May 10, 2017 5:15:00 PM