Abuse and Neglect, Boehringer Ingelheim, Diabetes, Endocrinology, Lipids / 22.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35536" align="alignleft" width="131"]Dr-Robert-R-Henry.jpg Dr. Henry[/caption] 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.
AstraZeneca, Author Interviews, Boehringer Ingelheim, Diabetes, Eli Lilly, J&J-Janssen, Lipids, Merck / 19.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35424" align="alignleft" width="200"]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[/caption] 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.
Author Interviews, Diabetes, Pediatrics / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35296" align="alignleft" width="142"]Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhau Prof. Danne[/caption] 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).
Author Interviews, Diabetes, Vegetarians, Weight Research / 12.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35233" align="alignleft" width="200"]Hana Kahleova, MD, PhD</strong> Director of Clinical Research at Physicians Committee for Responsible Medicine Physicians Committee for Responsible Medicine Charles University in Prague Dr. Kahleova[/caption] Hana Kahleova, MD, PhD Director of Clinical Research at Physicians Committee for Responsible Medicine Physicians Committee for Responsible Medicine Charles University in Prague MedicalResearch.com: What is the background for this study? What are the main findings? Response: The vegetarian diet was found to be almost twice as effective in reducing body weight, resulting in an average loss of 6.2kg compared to 3.2kg for the conventional diet. Using magnetic resonance imaging, we studied adipose tissue in the subjects’ thighs to see how the two different diets had affected subcutaneous, subfascial and intramuscular fat. We found that both diets caused a similar reduction in subcutaneous fat. However, subfascial fat was only reduced in response to the vegetarian diet, and intramuscular fat was more greatly reduced by the vegetarian diet.
Author Interviews, Diabetes / 10.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35200" align="alignleft" width="150"]Katrina Donahue MD, MPH Professor, Director of Research, UNC Family Medicine. Co-Director,  North Carolina Newtork Consortium (NCNC). Chapel Hill, NC Dr. Donahue[/caption] Katrina Donahue MD, MPH Professor, Director of Research, UNC Family Medicine. Co-Director, North Carolina Newtork Consortium (NCNC). Chapel Hill, NC MedicalResearch.com: What is the background for this study? Response: Type 2 diabetes is an epidemic affecting one in 11 people in the United States. For those treated with insulin, checking blood sugar with a finger stick at home is an accepted practice for monitoring the effects of insulin therapy. However, the majority of patients with type 2 diabetes are not treated with insulin. These patients, too, are often recommended glucose monitoring, despite an ongoing debate about its effectiveness in controlling diabetes or improving how patients feel. Currently, 75 percent of non-insulin treated type 2 diabetes patients perform regular blood glucose testing at home, generally at the recommendation of a provider. “The MONITOR Trial” is the first large pragmatic study examining glucose monitoring in the United States.