Erectile Dysfunction Should Be a Marker For Diabetes

MedicalResearch.com Interview with:

Damiano Pizzol  Operational Research Unit, Doctors with Africa Cuamm Beira, Mozambique

Damiano Pizzol 

Damiano Pizzol 
Operational Research Unit, Doctors with Africa Cuamm
Beira, Mozambique

MedicalResearch.com: What is the background for this study?

Response: Since the 1970s the association between diabetes and the development of erectile dysfunction has been documented both in animal models and humans Several studies have considered the prevalence of erectile dysfunction in diabetes and the majority agree that the incidence of erectile dysfunction in men with diabetes is two- to three-fold higher than in the general population. It is estimated that erectile dysfunction affects up to 75% of all men with diabetes, it is age correlated and occurs at a younger age in men with diabetes.
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Women With Early Menopause At Higher Risk of Diabetes

MedicalResearch.com Interview with:

Eralda Asllanaj Department of Epidemiology Erasmus University Medical Center Rotterdamthe Netherlands

Eralda Asllanaj

Eralda Asllanaj
Department of Epidemiology
Erasmus University Medical Center
Rotterdamthe Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is known that women with early onset of menopause (age below 45 years) have an increased risk of cardiovascular disease and overall mortality. This increased risk is thought to be due to the adverse effects of menopause on cardiovascular risk factors.

Type 2 diabetes is a major risk factor for cardiovascular disease, but it remains unclear whether age at menopause affects the risk of developing type 2 diabetes. Our study shows that women who experience menopause before the age of 40 were almost 4 times more likely to develop type 2 diabetes than those experiencing menopause after 55 years old. Moreover, those who had menopause between 40 to 44 years were 2.4 times more likely to have diabetes later in life. The risk of having diabetes reduced by 4 % per year older the women experienced menopause. Adjustment for the various confounding factors and differences in genetic predisposition to early menopause did not affect the results.

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Novo Nordisk and Glooko Launch Cornerstones4Care® App To Help Manage Diabetes

MedicalResearch.com Interview with:

David Moore MBA Senior Vice President of Marketing Novo Nordisk 

David Moore

David Moore MBA
Senior Vice President of Marketing
Novo Nordisk 

MedicalResearch.com: What is the Cornerstones4Care Powered by Glooko (C4C) App?

Response: The Cornerstones4Care® Powered by Glooko® App marries Novo Nordisk’s extensive knowledge of diabetes and personalized patient support with Glooko’s digital platform and data analytics expertise. The App is comprehensive tool that helps patients track meals, activity, medicine and blood sugar – in one convenient place – and is intended to help people learn how to better manage diabetes through their mobile devices.

MedicalResearch.com: What functions will people with diabetes have access to? How can the app help people living with diabetes control their disease?   

Response: The Cornerstones4Care® Powered by Glooko® App marries Novo Nordisk’s extensive knowledge of diabetes and personalized patient support with Glooko’s digital platform and data analytics expertise. The App is comprehensive tool that helps patients track meals, activity, medicine and blood sugar – in one convenient place – and is intended to help people learn how to better manage diabetes through their mobile devices.

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Supply and Demand for Diabetes Prevention Programs

MedicalResearch.com Interview with:

Maria L. Alva, DPhil Economist RTI International -  Research Triangle Institute

Dr. Alva

Maria L. Alva, DPhil
Economist
RTI International –  Research Triangle Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have strong evidence from trials of structured lifestyle intervention programs (e.g. the Diabetes Prevention Program (DPP)) showing that half of new diabetes cases could be avoided if persons with prediabetes changed their lifestyle habits to lose a modest amount of body weight. Moreover, the DPP has been successfully translated into cost-effective community-based prevention interventions, but nationally, these evidence-based interventions (EBIs) are not being used sufficiently. To scale up the implementation of diabetes prevention EBIs, we need to address the challenges of getting organizations to adopt EBIs, and community members to enroll.

Because cost is a primary barrier we wanted to understand what was the perceived value and demand for diabetes prevention programs in NC. And in particular, the role that community health workers and technology could play in program delivery, from the perspectives of both potential recipients (adults at high risk or diagnosed with prediabetes) and decision-makers in healthcare/public health delivery.

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Eyedrop Kallikrein Inhibitor Shows Promise for Diabetic Macular Edema

MedicalResearch.com Interview with:
Dr. David Kita, PhD Founder and Head of R&D Verseon CorporationDr. David Kita, PhD
Founder and Head of R&D
Verseon Corporation

MedicalResearch.com: What is the background for this study?

Dr. Kita: The preclinical data presented at the 2017 BIO International Conference provided details about Verseon’s plasma kallikrein inhibitors for the treatment of diabetic macular edema (DME).

DME affects millions of people worldwide and is a major cause of vision loss in patients with diabetes mellitus. Upregulation of the kallikrein-kinin system in response to diabetes can result in retinal vascular permeability, which can damage the retina and eventually lead to the central vision loss associated with DME.

The current treatment options for DME include intravitreal injections of anti-VEGF agents or corticosteroids into the eye and surgical laser treatments. Long-term use of intravitreal injections is associated with side effects such as inflammation, infections, and cataracts. For anti-VEGF drugs in particular, there is also a growing concern about geographic atrophy. In addition, about 50% of patients reported at most moderate vision improvements following anti-VEGF therapy in clinical trials. This highlights the need for a new treatment that can serve as a monotherapy or as an adjuvant to current therapies.

At Verseon, we are working on inhibitors of the serine protease plasma kallikrein (KLKB1) that can be administered either topically or orally. Verseon’s unique computer-driven drug discovery platform allows us to design potent, selective drug candidates that are unlikely to be found using traditional approaches. We have generated a number of chemically distinct series of KLKB1 inhibitors and optimized multiple lead candidates, which show good activity, permeability, and solubility.

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Newer Insulin Formulation Reduces Risk of Hypoglycemia

MedicalResearch.com Interview with:

Wendy Lane MD Director of Clinical Research Mountain Diabetes and Endocrine Center Asheville, NC 

Dr. Lane

Wendy Lane MD
Director of Clinical Research
Mountain Diabetes and Endocrine Center
Asheville, NC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The SWITCH1 trial was the first double blinded insulin trial to compare the rate of severe, nocturnal severe and symptomatic blood glucose-confirmed hypoglycemia between two basal insulins, insulin glargine U100 and insulin degludec U100, in patients with type 1 diabetes.

The trial design (double blinded crossover treat-to-target) eliminated any bias in the results, which showed clear-cut reductions in all categories of hypoglycemia with insulin degludec compared to insulin glargine.

Severe hypoglycemia has dangerous and greatly feared consequences including cognitive impairment, seizures, coma and death, and it is the main barrier to effective use of insulin in the treatment of type 1 diabetes. Insulin degludec, which was shown to reduce the risk of hypoglycemia compared to insulin glargine in the SWITCH1 trial, should be viewed by clinicians as an advancement in insulin therapy which will increase its safety and improve the quality of life of our patients with type 1 diabetes.

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Vitamin A Derivative May Have Anti-Diabetic Capabilities

MedicalResearch.com Interview with:

Stefan Amisten, PhD The Oxford Centre for Diabetes, Endocrinology & Metabolism University of Oxford, Oxford Diabetes Research Group, Division of Diabetes & Nutritional Sciences King’s College London, Faculty of Life Sciences & Medicine, London UK

Dr. Armisten

Stefan Amisten, PhD
The Oxford Centre for Diabetes, Endocrinology & Metabolism
University of Oxford, Oxford
Diabetes Research Group, Division of Diabetes & Nutritional Sciences
King’s College London, Faculty of Life Sciences & Medicine, London
UK

MedicalResearch.com: What is the background for this study?

Response: Type 2 diabetes is a global epidemic that is causing an increasing medical and financial burden on both individuals and society in general. Type 2 diabetes is characterized by insulin resistance, poor insulin response to blood glucose which leads to chronically elevated blood glucose and damage to the cardiovascular system and other organs, which may ultimately lead to blindness, kidney failure, blindness, toe amputations, cardiovascular disease and premature death. Although a number of drugs are available for the treatment of Type 2 diabetes, no drug is currently able to cure diabetes, as they are only able to slow down the disease progression. There is therefore a need to develop novel therapies to treat Type 2 diabetes.

G-protein coupled receptors (GPCRs) constitute a family of almost 400 cell surface receptors that is the target of a large number of modern medicines. Interestingly, only a small subset of all GPCRs are currently targeted by modern medicines, which means that a large number of GPCRs still have untapped therapeutic potential, largely because they have not been studied in-depth, or because their ligands (i.e. binding partners) have not been identified.

This study is a result of a thorough cataloguing of all G-protein coupled receptors (GPCRs) in human pancreatic islets (Amisten et al. Pharmacol Ther. 2013 Sep;139(3):359-91.), where the receptor GPRC5C was identified as one of the most abundant orphan GPCRs in human islets.

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PCSK9 Inhibitor Praluent Added to Statins Improved Lipid Profile in Diabetes

MedicalResearch.com Interview with:

Dr-Robert-R-Henry.jpg

Dr. Henry

Robert R. Henry, M.D.
Professor of Medicine
Member of the ODYSSEY DM Steering Committee and
Director of the Center for Metabolic Research
VA San Diego Healthcare System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The ODYSSEY DM-DYSLIPIDEMIA trial was a randomized, open-label, parallel-group study designed to evaluate the superiority of Praluent versus usual care in 413 patients with type 2 diabetes with mixed dyslipidemia at high cardiovascular (CV) risk, not adequately controlled with maximally tolerated dose (MTD) statins. The primary endpoint was percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to week 24.

In ODYSSEY DM-DYSLIPIDEMIA, Praluent 75 mg was added to MTD statins, with dose adjusted at week 12 to 150 mg every two weeks if their non-HDL-C was greater than or equal to 100 mg/dL at week 8. Approximately 64 percent of patients reached their lipid goals with the Praluent 75 mg dose.

Results from the ODYSSEY DM-DYSLIPIDEMIA study found that Praluent added to MTD statins showed significant reduction in non-HDL-C and other lipid parameters compared to those on usual care.

Praluent was superior to usual care in lowering non-HDL-C (37.3 percent and 4.7 percent, for the usual care arm). The mean difference between the two treatment arms was -32.5 percent (p<0.0001).

Praluent in combination with MTD statins reduced LDL-C by 43 percent from baseline compared to a 0.3 percent increase for usual care (p<0.0001). Treatment with Praluent also improved the overall lipid profile.

There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Furthermore, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.

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Adding Praluent (Alirocumab) To Statins Reduces LDL in High Cardiovascular Risk Diabetics

MedicalResearch.com Interview with:

Lawrence Leiter, M.D. MDCM, FRCPC, FACP, FACE, FAHA Chair of the ODYSSEY DM Steering Committee and Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute St. Michael’s Hospital University of Toronto, Canada

Dr. Lawrence Leiter

Lawrence Leiter, M.D. MDCM, FRCPC, FACP FACE, FAHA
Chair of the ODYSSEY DM Steering Committee and
Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute
St. Michael’s Hospital
University of Toronto, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The ODYSSEY DM-INSULIN trial was a randomized, double-blind, placebo-controlled, multicenter study that evaluated alirocumab (Praluent) in 517 patients with insulin treated type 1 and type 2 diabetes with high cardiovascular (CV) risk and hypercholesterolemia despite maximally tolerated dose (MTD) statins. The primary endpoint was percent change in calculated LDL-C from baseline to week 24.

Alirocumab 75 mg every two weeks was added to MTD statins, with the dose increased at week 12 to 150 mg every two weeks if the LDL-C at week 8 was greater than or equal to 70 mg/dL. In fact, only about 20% of the alirocumab treated participants required the higher dose.

Results of the type 2 diabetes study population (n=441) showed that the addition of alirocumab to MTD statin therapy, reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was -49 percent (p<0.0001). Treatment with alirocumab also improved the overall lipid profile. Furthermore, no new safety issues were identified.

There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Additionally, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.

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Oral Sotagliflozin On Top of Optimized Insulin Significantly Reduced A1C

MedicalResearch.com Interview with:

Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhau

Prof. Danne

Prof. Dr. Thomas Danne
Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc
Kinder und Junden Krankenhaus

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The double-blind, placebo controlled, Phase 3 study known as inTandem2 randomized 782 adult patients from 99 sites in the EU and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured.

The mean baseline A1C levels after the six-week optimization period were 7.8%, 7.7% and 7.7% for patients randomized to the placebo, 200mg and 400mg arms, respectively (A1C was 8.4% across all dose arms prior to insulin optimization).

The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). In response to regulatory input, a secondary endpoint to measure “net clinical benefit” was defined for this study as the proportion of patients at week 24 who achieved the standard of care A1C goal of less than 7.0% without any episode of severe hypoglycemia or DKA. 15% of patients in the placebo arm, 32% in the 200 mg dose arm and 32% in the 400mg dose arm achieved this endpoint (p<0.001 for both treatment arms).

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