AstraZeneca recently announced that they have received a Complete Response Letter (CRL) from the FDA in regards to their New Drug Application (NDA) for a combination of saxagliptin and dapagliflozin. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and dapagliflozin is an SGLT2 inhibitor.
The FDA’s response requires AstraZeneca to show more clinical data about the safety and efficacy of this new combination product. The FDA may require AstraZeneca to submit data from new trials in addition to data from previous and ongoing studies. AstraZeneca has stated that the FDA’s response will likely not affect the individual drugs in the combination, saxagliptin and dapagliflozin, which are already on the market and have been FDA approved for treatment of type 2 diabetes.
AstraZeneca previously reported positive phase III trial data earlier this year. The company has stated it will continue to work closely with the FDA and other regulatory agencies to continue to pursue the approval of the new combination drug.
The FDA has requested more clinical data from AstraZeneca regarding a new diabetes drug, a combination product with saxagliptin and dapagliflozin.
Approval, marketing, and use of the individual components – saxagliptin and dapagliflozin – are unaffected by this decision.
This week we focus on some different ideas on controlling obesity and weight in our patients. Although many of the studies we read about sound good, they don’t work for everybody. In addition, individual life schedules make doing the right things, once they find them, difficult as well. Next, we have to throw in the co-morbidities often associated with obesity and try to treat those. When we add all these factors together, what seems like easy solutions become a jumbled nightmare.
If you look at article 5, Resistance Exercise and Appetite Regulation in Type 2 Diabetes, your patients can do better by timing their exercise, while article 6 looks at three different ways to eat to improve weight control. However, all of this might be impossible if your patient is using some of the medications that Dr. Sheri Colberg talks about in her special feature this week.
Oh, and don’t forget if you think you are as smart as our writers and researchers, then I challenge you to click here and take the A1C Challenge.
DIC Publisher Steve Freed will be attending the GTCbio 2016 Diabetes Summit, to be held April 25-27, 2016 in Boston, MA. This unique event encompasses the drug discovery and partnering aspects of diabetes in two individual conferences that take place concurrently. Click here for more information.
Our web site CME resource is back online! Be sure to check out the new CME courses posted there. Courses are currently available on topics including: Advances in the Medical & Surgical Management of Obesity; Diabetic Retinopathy; Strategies to Improve Prevention and Treatment of Diabetes; and more!
The Genteel Lancing Instrument is a comfortable alternate site lancing device that fits easily into the travel and organizer pouch that is included with the instrument. It comes in five colors with stickers for children to apply. Imagine no more fear or discomfort to make you want to check more often. Learn more here and watch our video interview with the inventor of the Genteel lancet device.
Mr. Carlson is a 52-year-old Caucasian grocery store manager you saw last week for a new patient visit. His labs from that visit were significant for elevated random plasma glucose 166 mg/dL, A1C 7.4% and elevated lipids (TG=175 mg/dL, LDL 148 mg/dL, HDL 38 mg/dL, total cholesterol 221 mg/dL). He has returned to your clinic for a follow-up appointment. His physical exam is notable for central abdominal obesity (waist circumference 42”), left eyelid xanthelasma, BP 147/91, HR 72, RR 18, BMI 36 kg/m2, but otherwise normal. A repeat A1C test shows A1C 7.6%. Mr. Carlson smokes between 1 and 1.5 packs of cigarettes daily. After discussing the labs and your findings with Mr. Carlson, you begin collaborating on a management plan. You write prescriptions for metformin, a statin and ACE inhibitor. Mr. Carlson doesn’t think “taking medication will be too tough,” but expresses skepticism about your recommendations for a change in his diet, exercise and smoking programs because he has tried them, without success, in the past.
Mr. Carlson makes an appointment with a registered dietitian. She discusses with him the benefits of medical nutrition therapy for weight, glycemic control, blood pressure, lipid profile and overall wellbeing. Which following statement regarding macronutrients is true?
D. There is no single ideal dietary distribution of calories among carbohydrates, fats, and proteins for people with diabetes.
A record number of physicians graduated with flying colors from the American Board of Obesity Medicine’s (ABOM’s) certified examination in December 2015, as the nation struggles to fill the burgeoning need for specialists who know how to treat obesity. The results from the ABOM show that 429 examinees passed the test late last year, including 10 physicians who were recertified. The latest group includes 141 internists, 123 family physicians, 33 endocrinologists, 28 pediatricians, 24 obstetricians/gynecologists, and 10 surgeons. This latest group brings the number of first-time diplomates to have passed the ABOM certification exam to 761 in the past two years — 342 of them in 2014 — according to the National Board of Medical Examiners. The continued need for more board-certified obesity-medicine specialists is supported by the ever-increasing girth of the nation. According to the Centers for Disease Control and Prevention, 78.6 million US adults are obese (34.9% of the population). American Board of Obesity Medicine 3/2016
Research indicates setting more aggressive blood pressure goals for diabetic patients may cause harm.
European committee affirms benefits of SGLT-2s while urging healthcare providers to be vigilant and educate patients for signs and symptoms of atypical DKA.
Intermittent energy restriction and other approaches to timing and frequency of meals may affect well-being.