Dapagliflozin (Farxiga®)Added to Insulin for Type 1 Diabetes May Improve Glycemic Control

MedicalResearch.com Interview with:

Chantal Mathieu, MD, PhD Professor of Medicine Clinical and Experimental Endocrinology Catholic University of Leuven, Belgium

Dr. Mathieu

Chantal Mathieu, MD, PhD
Professor of Medicine
Clinical and Experimental Endocrinology
Catholic University of Leuven, Belgium

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

Response: People with type 1 diabetes (T1D) are confronted often with the inability to achieve satisfactory glycemic control, being good HbA1c, but in particular stable glycemic control, avoiding hyperglycemic events, but also hypoglycemic events, despite novel insulins and novel technologies. Moreover, intensive insulin therapy is often associated with weight gain, leading to an increase in overweight and obesity also in people with T1D. All of these issues affect quality of life.

In the DEPICT 2 study we examined the impact of adding a selective SGLT2 inhibitor, dapagliflozin (two doses tested – 5 and 10mg) in a double blinded manner versus placebo to background insulin (MDI or CSII) in people with T1D reaching insufficient glycemic control (HbA1c 7.5-10.5%). Primary endpoint was lowering in HbA1c at 24 weeks and secondary endpoints included insulin dose reduction and weight reduction as well as a composite endpoint of having a HbA1c drop of >=0.5% without severe hypoglycemia. The study ran internationally, with about 1/3 of patients coming from North America, 1/3 from Europe and 1/5 from Asia (Japan).

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Developing a Pill That Mimics Effects of Gastric Bypass Surgery

MedicalResearch.com Interview with:

Jeff Karp B.Eng. PhD. Professor of Medicine Center for Nanomedicine and Division of Engineering in Medicine Brigham and Women’s Hospital, Harvard Medical School Boston MA

Prof. Karp

Jeff Karp B.Eng. PhD.
Professor of Medicine
Center for Nanomedicine and Division of Engineering in Medicine
Brigham and Women’s Hospital
Harvard Medical School
Boston MA

MedicalResearch.com: How would you briefly explain the most important findings and conclusions of this study to a non-expert?

  • The type-2 diabetes (T2D) epidemic will affect over 642 million people worldwide by 2040. As a result, diabetes costs the US healthcare over $174 billion dollars annually and is the leading cause of blindness, amputations, renal failure, and poor cardiovascular outcomes. Recently, bariatric surgery, bypassing stomach and intestine from the food stream, has shown promising results and shown to be superior to pharmaceuticals in managing T2D. However, the risks of surgery along with permanent changes to gastrointestinal anatomy deters many suitable patients from surgery, with less than 1-2% of Americans who qualify for weight loss surgery actually undergoing the procedure. Therefore, there is an urgent need for a safe, non-invasive and effective treatment for wider diabetic patient population.
  • We envisioned a pill that a patient can take before a meal that transiently coats the gut to replicate the effects of surgery. During the past 8 years, we’ve been working on this idea and have developed a safe gut-coating material that can potentially mimic the beneficial effects of gastric bypass procedures in the form a pill.
  • LuCI can be activated in any part of gastrointestinal tract (e.g. stomach, duodenum, intestine, colon) to form a temporary physical barrier that isolates that part of gastrointestinal tract. In our pre-clinical models, LuCI coated the duodenum to modulate glucose responses in oral glucose tolerance tests.
  • These beneficial effect are observed without any evidence of systemic absorption of the drug.
  • We believe that LuCI could be a new therapeutic approach for T2D that is based on Roux-en-Y gastric bypass surgery, but is safer, associated with significantly less complications, and thus can potentially help a wide T2D patient population.
  • In a separate set of studies, we also showed that luCi allows delivery of certain proteins and drugs, which would normally be degraded by the gastric acid, to the GI tract, protecting it from gastric acid digestion and prolonging their luminal exposure.

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Physician MOC Status Linked To Better Diabetes Performance Measure

MedicalResearch.com Interview with:
Bradley Gray, PhD
Senior Health Services Researcher
American Board of Internal Medicine

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

Response: This study is part of an ongoing effort to improve and validate ABIM’s MOC process through the use of real data that is ongoing here at ABIM.

MedicalResearch.com: What are the main findings? 

Response: The paper examines the association between MOC status and a set of HEDIS process quality measures for internists twenty years past the time they initially certified. An example of one HEDIS performance measure we looked at was percentage of patients with diabetes that had twice annual HbA1c testing. The key findings of the paper are that physicians who maintained their certification had better scores on 5 of 6 HEDIS performance measures than similar physicians who did not maintain their certification.

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Obese Women Remain at Risk For Heart Disease, Even When Metabolically Healthy

MedicalResearch.com Interview with:
Nathalie Eckel, MSc

German Diabetes Center
Düsseldorf, Germany 

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

 Response: Obesity is associated with metabolic disorders such as diabetes, high blood pressure and hypercholesterolemia, and with a higher risk of cardiovacular disease compared to normal weight. However, there is also the phenomenon of the so-called “metabolically healthy obesity” and “metabolically unhealthy normal-weight”. So far it has been unclear how metabolic risk factors change over time in metabolically healthy people depending on body weight and what cardiovascular disease risk results from this.

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Artificial Pancreas Reduces Hypoglycemia in Type 1 Diabetes

MedicalResearch.com Interview with:

Dr-Apostolos Tsapas

Dr. Tsapas

Apostolos Tsapas, MD PhD MSc(Oxon)
Associate Professor of Medicine
Director of the Second Medical Department | Aristotle University Thessalonik
Cruddas Link Fellow
Harris Manchester College
University of Oxford  

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

Response: Artificial pancreas treatment, also referred to as closed loop glucose control, is an emerging treatment option combining a pump and continuous glucose monitoring with a control algorithm to deliver insulin (and potentially glucagon) in a glucose responsive manner. Compared with insulin pumps or sensor augmented pumps, artificial pancreas use can reduce the burden for patients by automatically adjusting the amount of insulin entering the body on the basis of sensor glucose levels. The US Food and Drug Administration has recently approved the first artificial pancreas system for use by people with type 1 diabetes over 14 years of age, based on a safety outpatient study.

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Which Diabetes Meds Reduce Heart Failure and Death?

MedicalResearch.com Interview with:

Sean Lee Zheng BM BCh MA MRCP Cardiovascular Division King's College Hospital London British Heart Foundation Centre of Research Excellence London, UK

Dr. Zheng

Sean Lee Zheng BM BCh MA MRCP
Cardiovascular Division
King’s College Hospital London
British Heart Foundation Centre of Research Excellence
London, UK

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

Response: The growing prevalence of type 2 diabetes and its associated burden on cardiovascular disease is a global problem. A number of drug treatments effective in lowering blood glucose are now available, with the three latest drug classes developed being the DPP-4 inhibitors, GLP-1 agonists and SGLT-2 inhibitors. While the use of medications from these three classes are increasing, it remains unknown how they compare in lowering the risk of death or cardiovascular disease. This leads to clinical uncertainty when it comes to introducing new medicines for our patients. Our study aimed to use data from randomized clinical trials in a network meta-analysis, allowing these three drug classes to be compared with one another.

Our study, which included 236 studies enrolling 176310 participants, showed that the use of SGLT-2 inhibitors or GLP-1 agonists were associated with a lower risk of death than with DPP-4 inhibitors. SGLT-2 inhibitors had additional beneficial effects on heart failure events compared with the other two drug classes.

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Screening Criteria Can Miss Over Half of Adults with Prediabetes

MedicalResearch.com Interview with:
“Diabetes Mellitus” by Steve Davis is licensed under CC BY 2.0Matthew James O’Brien MD

Assistant Professor, Medicine
General Medicine Division
Assistant Professor, Preventive Medicine
Northwestern University 

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

Response: The USPSTF is an expert group that makes recommendations for screening and other preventive services. In December 2015, they recommend that providers screen for diabetes in patients who are 40-70 years old and also overweight/obese. The same recommendation stated that clinicians “should consider screening earlier” in patients who have any of the following risk factors: non-white race/ethnicity, family history of diabetes, or personal history of gestational diabetes or polycystic ovarian syndrome. Using nationally representative data, we studied the performance of the “limited” criteria based on age and weight alone vs. the “expanded criteria” mentioned above.

The main findings were that following the “limited” screening criteria of age and weight would result in missing over 50% of adults with prediabetes and diabetes. In other words, if providers followed the “limited” criteria, over 50% of adults with prediabetes and diabetes would not get screened. The “expanded” criteria exhibited much better performance, resulting in 76.8% of adults with prediabetes and diabetes who would be screened.  Continue reading

Obese Children Who Lose Weight Before Adulthood Can Reduce Risk of Diabetes

MedicalResearch.com Interview with:

Lise Geisler Bjerregaard PhD

Dr. Geisler Bjerregaard

Lise Geisler Bjerregaard PhD
Postdoc, PhD, M.Sc. Public Health
Center for Klinisk Forskning og Sygdomsforebyggelse/ Center for Clinical Research and Disease Prevention
Sektion for Klinisk Epidemiologi
Frederiksberg Hospital, Frederiksberg

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

Response: Being overweight in childhood and early adulthood is associated with an increased risk of developing type 2 diabetes in adulthood. We wanted to know whether or not remission of overweight before early adulthood can reduce the risks of type 2 diabetes later in life.

We studied the associations between different combinations of weight status in childhood, adolescence and early adulthood, and later development of type 2 diabetes.

We found that men who had been overweight at 7 years of age but normalised weight by age 13 years and were normal weight as young men had similar risks of type 2 diabetes as men who were never overweight. Men who normalised weight between age 13 years and early adulthood had increased risks of type 2 diabetes, but lower risks than men who were overweight at all ages.  Continue reading

DPP-4 inhibitor Class of Diabetes Medications Linked To Increase Risk of Inflammatory Bowel Disease

MedicalResearch.com Interview with:
Devin Abrahami,
graduate student
Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal
Department of Epidemiology, Biostatistics, and Occupational Health
McGill University, Montreal, QC, Canada

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

Response: The goal of our study was to assess whether a class of antidiabetic drugs, the dipeptidyl peptidase-4 (DPP-4) inhibitors, is associated with the risk of inflammatory bowel disease (IBD). While these drugs control blood sugar levels in patients with type 2 diabetes, there is some evidence that they may also be involved in immune function, and possibly in conditions such as IBD.

In our study, we found that the use of DPP-4 inhibitors was associated with a 75% increased risk of IBD, with the highest risk observed after three to four years of use. Continue reading

Cardiovascular Trials Need Better Characterization of Heart Failure in Diabetics

MedicalResearch.com Interview with:

Stephen J. Greene, MD Division of Cardiology Duke University Medical Center Durham, NC

Dr. Greene

Stephen J. Greene, MD
Division of Cardiology
Duke University Medical Center
Durham, NC

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

Response: In 2008, the United States FDA issued an industry guidance specifying that diabetes drugs should routinely be tested in large cardiovascular outcome trials to confirm cardiovascular safety. The guidance specifically mentioned cardiovascular safety in terms of MACE, or major adverse cardiac events, including cardiovascular death, myocardial infarction, and stroke.  Largely because of this, these trials have traditionally had a focus on cardiovascular disease in terms of atherosclerotic events. Heart failure was not mentioned in the FDA document and these trials have had a lesser focus on it.

As the years have gone by, we have learned more and more about the connection between diabetes and heart failure. There is tremendous overlap between the two patient populations. Also, as more and more of the large cardiovascular outcome trials have been completed, we have seen multiple examples of various glucose lowering therapies either increasing or decreasing risk of heart failure events. Given all these data on heart failure/ diabetes interactions, the goal of our research was to carefully examine all of the completed large cardiovascular outcome trials of diabetes therapies to systematically describe the type of heart failure-related data they capture. As an initial step in improving heart failure characterization in these trials, we wanted to first describe what trials have already been doing and where the gaps in understanding heart failure in these trials exist.

Overall, we found major gaps in the amount and quality of the heart failure data capture in these trials. We looked at 21 large trials, including over 150,000 patients. Rates of patients with baseline heart failure were inconsistently provided, and among those trials that did provide it, heart failure patients tended to be underrepresented compared to the general population. Patients with baseline heart failure were also poorly characterized, with minimal data on functional status, ejection fraction, or heart failure medications. Only 6 trials reported rates of new-onset heart failure and the definitions used were non-specific. Most trials tended to report rates of heart failure hospitalization, but did not include data on fatal or other types of heart failure events. Only 2 trials included heart failure events within the primary study endpoint. More details are included in our full manuscript, which was published in the Journal of the American College of Cardiology to coincide with our presentation at the ACC conference.

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Dietary Fiber Promotes Beneficial Bacteria, Improving Glucose Control in Diabetes

MedicalResearch.com Interview with:

Liping Zhao PhD, Professor Department of Biochemistry and Microbiology School of Environmental and Biological Sciences Rutgers University-New Brunswick NJ

Dr. Zhao

Liping Zhao PhD, Professor
Department of Biochemistry and Microbiology
School of Environmental and Biological Sciences
Rutgers University-New Brunswick NJ

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

Response: Microbes in the human gut (collectively known as the gut microbiota) provide many functions that are important for human health. A notable example is that some gut bacteria are able to ferment non-digestible carbohydrates in our diet, e.g. dietary fibers, to produce short-chain fatty acids (SCFAs). These SCFAs nourish our gut epithelial cells, reduce inflammation, and play a role in appetite control. Deficiency of SCFAs has been associated with many diseases including type 2 diabetes. Many gut bacteria have the genes (and therefore the capacity) to produce SCFAs from carbohydrate fermentation. However, we know little about how these bacteria, as individual strains and as a group, actually respond to an increased supply of carbohydrates. This is key to improve clinical efficacy of dietary fiber interventions to improve human health. Continue reading

Risk Factors For Sudden Death in Heart Failure with Preserved Ejection Fraction

MedicalResearch.com Interview with:

Muthiah Vaduganathan, MD MPH Heart and Vascular Center Brigham and Women's Hospital 

Dr. Vaduganathan

Muthiah Vaduganathan, MD MPH
Heart and Vascular Center
Brigham and Women’s Hospital 

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

Response: The prevalence of heart failure with preserved ejection fraction (HFpEF) is rising globally, yet no medical therapies are currently available to alter its natural history and its progression remains incompletely understood.

Sudden death may represent a target for therapy in this disease entity. In 1,767 patients with HFpEF enrolled in the Americas region of the TOPCAT trial, we found that sudden death accounts for ~20% of all deaths. Male sex and insulin-treated diabetes mellitus identify patients at higher risk for sudden death. Sudden death was numerically lower but not statistically reduced in those randomized to spironolactone.

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Coronary Bypass Preferable To Stenting For Diabetes With LV Dysfunction

MedicalResearch.com Interview with:

Dr. Jayan Nagendran MD, PhD, FRCSC Director of Research, Division of Cardiac Surgery Associate Professor, Department of Surgery Division of Cardiac Surgery University of Alberta

Dr. Nagendran

Dr. Jayan Nagendran MD, PhD, FRCSC
Director of Research, Division of Cardiac Surgery
Associate Professor, Department of Surgery
Division of Cardiac Surgery
University of Alberta

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

Response: The primary modalities of treatment of symptomatic coronary artery disease (coronary heart disease) are either percutaneous coronary intervention (coronary stunting) or coronary artery bypass grafting surgery. There are well designed clinical trials that guide clinical practice for the treatment of patients with diabetes requiring coronary revascularization and there are trials that examine the best modality of coronary revascularization in patients with left ventricular dysfunction. However, there is a lack of evidence for patients with both diabetes and left ventricular dysfunction. As such, we performed a propensity matched study of patients with diabetes and left ventricular dysfunction undergoing either percutaneous coronary intervention compared to coronary artery bypass grafting surgery. We used our provincial database that captures >100,000 patients undergoing coronary angiography to attain our two cohorts for comparison.

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Bariatric Surgery Associated With Reduced Need For Diabetes Medications at Six Years

MedicalResearch.com Interview with:
Dr Jérémie Thereauz
Praticien Hospitalier
Chirurgie viscérale et digestive 

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

Response: Bariatric surgery has been proved to reduce type 2 diabetes in morbid obese patients. However, results of bariatric surgery at a nationwide level are lacking.

The aim of our study was to assess the 6-year antidiabetic treatment continuation, discontinuation or initiation rates after BS compared with matched control obese patients.

This large-scale nationwide study confirms that bariatric surgery is responsible for a significant 6-year postoperative antidiabetic treatment discontinuation rate compared to baseline and compared to an obese control group without surgery, and a low treatment initiation rate, with gastric bypass being the most effective procedure. 

MedicalResearch.com: What should readers take away from your report?

Response: This long term study confirms at a nationwide level, previous mid term randomized studies finding effiicency of bariatric surgery in type 2 diabetes for patients with morbid obesity associated.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Patients and physicians must be aware that morbid obesity still remains a chronic disease even after bariatric surgery, as 50% of patients with pre-existing antidiabetic treatment remained on treatment 6 years after surgery. Our study highlights the message that these patients require careful lifelong follow-up to monitor obesity complications. Complementary medico-economic study would be helpful to determine the relevance of such treatment in a national health care system.

No disclosures

Citations:

Thereaux J, Lesuffleur T, Czernichow S, Basdevant A, Msika S, Nocca D, Millat B, Fagot-Campagna A. Association Between Bariatric Surgery and Rates of Continuation, Discontinuation, or Initiation of Antidiabetes Treatment 6 Years Later. JAMA Surg. Published online February 14, 2018. doi:10.1001/jamasurg.2017.6163

https://jamanetwork.com/journals/jamasurgery/fullarticle/2672216?resultClick=1

 

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Irregular or Rotating Night Shifts Linked To Increased Risk of Diabetes

MedicalResearch.com Interview with:
“Night Shift - Hard@Work (5of8)” by cell105 is licensed under CC BY 2.0Dr. Céline Vetter

Assistant Professor
Department of Integrative Physiology
University of Colorado at Boulder
Boulder, CO

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

Response: Shift work, particularly night shifts, can change our social rhythms, as well as the internal biological rhythms including our sleep, and these effects could explain why shift work is linked to conditions such as obesity and type 2 diabetes. However, we don’t know which type of shift pattern is most strongly linked to type 2 diabetes. In addition, we know that some lifestyle factors can modify the link between a genetic predisposition to a disease and the disease itself, but we don’t know if this applies to shift work and type 2 diabetes.

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