Journal of Diabetes News

Journal of DiabetesVolume 7, Issue 2 p. 145-149 Journal of Diabetes NEWSFree Access Journal of Diabetes News First published: 18 November 2014 https://doi.org/10.1111/1753-0407.12247AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Emily E. Regier, Manu V. Venkat, and Kelly L. Close are of Close Concerns (http://www.closeconcerns.com), a healthcare information company focused exclusively on diabetes and obesity care. Close Concerns publishes Diabetes Close Up and Closer Look, periodicals that bring together news and insights in these areas. Each quarter, the Journal of Diabetes includes this News feature, in which Regier, Venkat, and Close review the latest developments relevant to researchers and clinicians. Readers of Journal of Diabetes involved in the clinical care of patients with diabetes (including students and educators) may request a complimentary 1-year subscription to Close Concerns' monthly newsletter, Diabetes Close Up (kelly.close@closeconcerns.com). Ninth Annual Cardiometabolic Health Congress (CMHC 2014) The Ninth Annual Cardiometabolic Health Congress was held 22–25 October 2014 in Boston, MA, USA. The conference drew over 1500 clinicians from a variety of disciplines, including endocrinology, cardiology, and primary care, and the agenda featured a number of presentations on diabetes and obesity, although other conditions like hypertension, atherosclerosis, and dyslipidemia were also well represented. A major highlight of the meeting on the diabetes technology side was a presentation by Dr Ed Damiano (Boston University, Boston, MA, USA) of new data from three additional participants in his team's ongoing 11-day multicenter bionic pancreas study (n = 40 at four centers); results from the first two participants were reported in July at the Barbara Davis Center Keystone Conference: Practical Ways to Achieve Targets in Diabetes Care (http://closeconcerns.com/knowledgebase/r/91226388#Bihormonal_Bionic_Pancreas, accessed 24 November 2014). The bionic pancreas is a closed-loop device that consists of a continuous glucose monitor (CGM) and a pump that delivers both insulin and glucagon subcutaneously as directed by a computer algorithm, which calculates the required dose of insulin and/or glucagon every 5 min based on CGM data. The estimated mean HbA1c (based on projections from average blood glucose measurements over 11 days) of the five patients on the bionic pancreas was 6.4% (137 mg/dL); blood glucose measurements were below 60 mg/dL for 0.5% of the time and above 180 mg/dL for 17% of the time. Dr Damiano also presented results from the recently completed 2014 summer camp study of the bionic pancreas, which tested the device in six boys and 13 girls aged between 6 and 11 years, who each spent 5 days on the bionic pancreas and 5 days with standard diabetes care in a summer camp setting. Topline results showed that participants had a lower estimated mean HbA1c of 6.4% (all participants had HbA1c <7%) and spent significantly less time with a blood glucose level below 60 mg/dL (1.2% of the time) and above 180 mg/dL (17% of the time) while on the bionic pancreas compared with the control condition (data were not provided for the control condition). Dr Samuel Dagogo-Jack (University of Tennessee Health Science Center, Memphis, TN, USA) presented results from a recently published analysis1 of patients' preferences regarding their diabetes care. This systematic review analyzed three contingent valuation studies and 11 discrete choice experiments published since 1998 (although the majority were conducted in 2009 or later) and used willingness to pay per month (WTP; all values in USD) as a measure of the value patients placed on various factors associated with diabetes treatment. Results showed that, on average, patients rated strong HbA1c-lowering efficacy (WTP = $146–205 per 1% HbA1c improvement in some studies) as more important than weight control (WTP = $58–76) and avoidance of hypoglycemia (WTP = $45–94 for overall hypoglycemia and $72–94 for nocturnal hypoglycemia), although in one study that examined only patients treated with insulin WTP was only $28–36 per month for a 1% improvement in HbA1c. With regard to adverse events, avoiding nausea was the highest priority for patients (WTP = $124–220). For criteria related to drug administration, WTP was $50–108 for the choice of an oral therapy over an injectable, and was $86 for meal-independent injections ($117 for patients who had experience with prandial injections and $65 for those who did not). Obesity week The second annual ObesityWeek, a scientific meeting sponsored by The Obesity Society (TOS) and American Society for Metabolic and Bariatric Surgery (ASMBS), took place 2–7 November 2014 in Boston, MA, USA. The extensive 6-day conference featured scientific sessions, corporate symposia, and keynote addresses on a wide spectrum of topics in obesity therapy, from clinical management to basic science to public policy. Presentations on new results from the SCALE clinical trial program of Novo Nordisk's (Bagsvaerd, Denmark) Saxenda (liraglutide 3.0 mg for obesity) represented some of the most notable highlights of the conference. Dr Frank Greenway (Pennington Biomedical Research Center, Baton Rouge, LA, USA) presented results from new analyses of the SCALE Obesity and Prediabetes trial (n = 3733), demonstrating that 92% of participants treated with Saxenda lost weight compared with 65% of the placebo group. Categorically, 63% of the Saxenda group lost at least 5% of their baseline body weight (vs 27% of the placebo group); 33% lost at least 10% (vs 11% with placebo); and 14% lost at least 15% (vs 4% with placebo). Dr Greenway also presented data specifically for trial completers at 56 weeks: participants on Saxenda experienced a mean weight loss of 9.2% compared with 3.5% for those on placebo (P < 0.0001), which was greater than the 8% and 2.6%, respectively, seen in the primary analysis. In addition, participants in all body mass index (BMI) subgroups (<27–29.9, 30–34.9, 35–39.9, and >40 kg/m2) experienced significantly similar weight loss at 56 weeks (P = 0.054), ranging between 7.4% and 9.3%. Additional SCALE data demonstrated improvements in health-related quality of life (QOL) with Saxenda. Dr Robert Kushner (Northwestern University, Chicago, IL, USA) presented QOL data from the SCALE Diabetes trial (n = 846). That study assessed QOL and treatment satisfaction based on scores from two questionnaires: the Impact of Weight on Quality of Life (IWQoL) and the Diabetes Treatment Satisfaction Questionnaire status (DTSQs). After 56 weeks, the mean change in IWQoL-Lite score was an increase of 12 points with Saxenda compared with 7.8 points with placebo. This difference was driven primarily by a significantly greater improvement in physical function. Although there was no significant difference between the groups for other individual components of the score (self-esteem, sexual life, public distress, and work), the Saxenda group experienced improvements within the range typically considered clinically meaningful (7.7–12 point change). Patients treated with Saxenda also reported significantly greater improvements in treatment satisfaction: the mean change in the DTSQs score was an increase of 4 points with Saxenda compared with 2.5 points with placebo. Dr Ken Fujioka (Scripps Clinic, San Diego, CA, USA) presented data showing similar QOL improvements for both physical function and mental health from the SCALE Obesity and Prediabetes trial. The three assessments used in that study were: (i) the SF-36v2 health survey, a generic measure of health status; (ii) IWQoL-Lite; and (iii) Treatment Related Impact Measure (TRIM-Weight), which evaluates impacts of prescription anti-obesity medications on patient functioning and well being. All domains regarding physical health from the SF-36v2 results trended in a positive direction; specifically, the overall physical health score increased by approximately 3.7 points with Saxenda (vs ∼2 points with placebo). Similarly, the IWQoL-Lite scores for physical function, self-esteem, and sexual life all showed improvements within the 7.7–12 point clinically significant range in the Saxenda group. The TRIM-Weight results demonstrated a significant improvement in weight management with Saxenda compared with placebo, whereas all other domains (daily life, treatment burden, experience of side effects, and psychological health) showed relatively little difference. Dr Elisa Fabbrini (Washington University, St Louis, MO, USA) presented data from a post hoc analysis of the Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus (BLOOM-DM) study of Arena's (San Diego, CA, USA) and Eisai's (Tokyo, Japan) Belviq (lorcaserin). The analysis (n = 509) found a significant improvement in fasting plasma glucose (FPG) with Belviq compared with placebo after 2 weeks, prior to any significant difference in weight loss between the two groups. Specifically, from a baseline of approximately 160 mg/dL, the Belviq group experienced an average reduction of approximately 27 mg/dL, whereas the placebo group experienced an average reduction of approximately 15 mg/dL (P < 0.001). In addition, at Week 12 (when the first HbA1c measurements were taken), the Belviq group had an average HbA1c reduction of approximately 1% (vs ∼0.5% with placebo; baseline of 8%; P < 0.0001) despite having lost <4% of their body weight. Significant improvements in FPG and HbA1c were also seen in patients who did not achieve ≥5% weight loss with Belviq. American Diabetes Association/JDRF Research Symposium on Diabetes and the Microbiome The American Diabetes Association (ADA) and JDRF hosted a joint Research Symposium on Diabetes and the Microbiome in Chicago (IL, USA) on 27–29 October 2014. The meeting drew approximately 100 attendees and featured a variety of talks on the potential contribution of the bacterial population in the human gut to metabolic and immune dysfunction. Ms Alexandra Livanos (New York University School of Medicine, New York, NY, USA), presented preliminary results suggesting that early exposure to antibiotics can increase the risk of developing type 1 diabetes in mice and that this effect is mediated through changes in the diversity and composition of the gut microbiome. Dr Peggy Kendall (Vanderbilt University, Nashville, TN, USA) presented preclinical data showing that knocking out the B cell protein Bruton's tyrosine kinase (BTK) can protect non-obese diabetic (NOD) mice against developing type 1 diabetes and lead to a measurably different microbiome composition. Dr Sean Davies (Vanderbilt University) presented results of his research on the potential therapeutic use of bacteria that have been engineered to secrete N-acyl-phosphatidylehanolamine (NAPE), which is deficient in obese humans, or N-acylethanolamine (NAE), a metabolite of NAPE. The compounds are believed to act on peroxisome proliferator-activated receptor α, transient receptor potential vanilloid 1, and G-protein-coupled receptor 119 (GPR119), which are involved in the regulation of metabolic processes. Dr Davies' laboratory found that wild-type mice that ingested NAPE- or NAE-producing bacteria experienced less weight gain in response to a high-fat diet than mice with an unmodified strain of the same bacteria, or those that ingested water. If you are interested in receiving the full Close Concerns report on these conferences, please email Kelly Close (kelly.close@closeconcerns.com). Reference 1Von Arx L, Kjeer T. The patient perspective of diabetes care: A systematic review of stated preference research. Patient. 2014; 7: 283– 300. CrossrefPubMedWeb of Science®Google Scholar Company Updates September 25: Sanofi (Paris, France) announced the initiation of the INTENSE trial, a real-world observational study comparing Lyxumia (lixisenatide) with other injectable therapies (including rapid-acting insulin analogs) as an add-on to basal insulin in type 2 diabetes patients; the study will also examine specific factors impacting patients' adherence to treatment. The first of the planned 2400 study participants was enrolled in July (the study will enroll across several European countries), with interim results expected in 2015. October 3: Intarcia (Boston, MA, USA) released topline results from two Phase 3 trials of ITCA 650, its subcutaneously placed osmotic mini-pump for long-term (up to 1 year) delivery of exenatide. Results from the FREEDOM-1 study demonstrated significantly greater HbA1c reductions with two doses (40 and 60 μg/day) of ITCA 650 compared with placebo in 460 patients with type 2 diabetes on up to three oral medications. Mean HbA1c reductions with ITCA 650 after 39 weeks ranged from 1.4% to 1.7% from a mean baseline of 8.4%, with the largest reductions seen in patients on background metformin; patients with a higher baseline HbA1c (>8.5%) also experienced greater mean reductions (up to 2.1%). Results from the FREEDOM-1 High Baseline (HBL) study, which investigated the higher (60 μg/day) dose of ITCA 650 in 60 type 2 diabetes patients with a baseline HbA1c of 10%–12%, showed sustained mean HbA1c reductions of 3.4% (mean baseline = 10.8%) after 39 weeks, with 25% of patients achieving a target HbA1c <7%. The drug was well tolerated in both trials, with overall nausea rates in the low single digits over time and a 2%–3% discontinuation rate due to nausea. Patients in FREEDOM-1 also experienced weight loss on the order of 3–4 kg with ITCA 650. October 3: Eli Lilly (Indianapolis, IN, USA) announced the European approval of the Humalog (insulin lispro) 200 units/mL (U200) KwikPen. The U200 KwikPen holds the same volume of insulin (3 mL) as the U100 KwikPen, meaning it will hold the equivalent of 600 units instead of 300 units. It will be targeted towards patients with high rapid-acting insulin requirements (>20 units/day). October 9: Transition Therapeutics (Toronto, Ontario, Canada) announced that Eli Lilly (Indianapolis, IN, USA) has commenced a phase 2 trial of TT401 (LY2944876), the company's partnered once-weekly oxyntomodulin analog (glucagon-like peptide-1 (GLP-1)/glucagon dual agonist). The study, which began in mid-May, aims to enroll up to 375 patients with type 2 diabetes, who will be randomized to receive one of four doses of TT401, AstraZeneca's (London, UK) Bydureon (once-weekly exenatide), or placebo. The trial will consist of an initial 12-week double-blind period followed by a 12-week open-label period. The primary endpoint is change in HbA1c at 12 weeks, and secondary endpoints include change in HbA1c at 24 weeks and change in body weight at 12 weeks; primary completion is expected in May 2015. October 16: The first Phase 2 trial for Roche's (Basel, Switzerland) GLP-1/gastric inhibitory polypeptide (GIP) dual agonist RG7697 (MAR709/RO6811135) is currently recruiting participants. The trial aims to enroll 105 patients with type 2 diabetes on background metformin who will be randomized to receive daily injections of RG7697, Novo Nordisk's Victoza (liraglutide) or placebo for 12 weeks. The RG7697 and placebo groups are double blinded, whereas the Victoza group is open label. The primary endpoint is change in HbA1c from baseline at 8 weeks, and secondary endpoints include change in HbA1c, body weight, FPG and postprandial glucose at 12 weeks. The study has an estimated primary completion date of August 2015. October 22: Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the companies' empagliflozin/metformin fixed-dose combination, which is also under regulatory review in Europe. Because the product uses an immediate-release formulation of metformin, it will require twice-daily dosing. October 23: Beta-O2 (Rosh-Haayin, Israel) announced that the first participant has been implanted in the company's pilot study of its βAir Bio-Artificial Pancreas for type 1 diabetes. βAir is a macroencapsulation device that encases islet cells, protecting them from immune attack and supplying them with oxygen. The device is implanted under the skin in the lower abdominal region, and the patient must inject oxygen once daily into a port connected to the implant. The 2-year, open-label clinical trial is investigating the safety and efficacy of the device, encapsulating cadaveric human islets, in eight patients with type 1 diabetes. Primary completion is expected in March 2016. October 27: Merck (Whitehouse Station, NJ, USA) began a new Phase 1 trial investigating the safety, pharmacokinetics, and pharmacodynamics of the insulin candidate MK-2640. The study, which is not yet open for participant recruitment, has an estimated completion date of May 2015. Part 1 of the study will evaluate MK-2640 in healthy participants, whereas Part 2 will evaluate the candidate versus regular human insulin in participants with type 1 diabetes. The trial has an estimated enrollment of 40 participants. October 28: Sanofi (Paris, France) announced that in order to maintain reimbursement and access for Lantus (insulin glargine), it accepted a high level of rebates during payer negotiations in the US. As a result, Sanofi expects sales for the Diabetes Division to be flat in 2015. October 31: AstraZeneca (London, UK) announced the US approval of Xigduo XR, a once-daily fixed-dose combination of Farxiga (dapagliflozin) and extended-release metformin. Xigduo XR is indicated as an adjunct to diet and exercise in adults with type 2 diabetes for whom treatment with both dapagliflozin and metformin is appropriate. The product is already approved in Australia, and Xigduo (dapagliflozin/immediate-release metformin) is approved in the European Union. Volume7, Issue2March 2015Pages 145-149 ReferencesRelatedInformation

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