doi: 10.1111/1753-0407.12171

Journal of Diabetes 6 (2014) 389–393

Journal of Diabetes NEWS American Association of Clinical Endocrinologists 23rd Annual Scientific and Clinical Congress (AACE 2014) AACE 2014 was held from May 14–18 in Las Vegas, Nevada in the United States. The meeting brought together endocrinologists and other healthcare practitioners from the US and around the world. The agenda featured oral presentations of clinical data, poster presentations, debates, symposia, and corporate-sponsored sessions on a broad range of topics in endocrinology, including (but not limited to) diabetes and obesity. There were a number of data presentations on diabetes pharmacotherapy, and even on the use of diabetes pharmacotherapy in obese and/or prediabetic patients. Dr Xavier Pi-Sunyer (Columbia University, New York, NY, USA) presented results from Novo Nordisk’s (Bagsvaerd, Denmark) phase III SCALE Obesity and Prediabetes trial of liraglutide 3.0 mg in overweight and obese adults, with and without prediabetes. Liraglutide is branded as the type 2 diabetes drug Victoza in its lower doses. The trial enrolled 3731 people (mean baseline body mass index [BMI] 36 kg/m2) who were obese or overweight and did not have type 2 diabetes; 2283 (61%) had prediabetes. Participants on liraglutide 3.0 mg achieved a mean 8% weight loss, compared to 2.6% for those on placebo. In terms of weight loss thresholds, 63% of people on liraglutide achieved at least 5% weight loss (vs 27% for placebo) and 33%

achieved weight loss of at least 10% (vs 10% for placebo). Concomitant with the weight loss were improvements in waist circumference, BMI, fasting plasma glucose level, hemoglobin A1c, systolic blood pressure, and diastolic blood pressure. The most notable safety finding was an imbalance in gallbladder disorders and acute pancreatitis between groups. There were 2.7 events of gallbladder disorders per 100 patientyears of exposure (PYE), the experimental arm versus 1 in the placebo (n = 54 vs 9). Dr Pi-Sunyer hypothesized that this is due to the liraglutide arm’s greater weight loss, since weight loss is known to cause gallstones. The majority of the acute pancreatitis events were mild, and improved quickly upon discontinuation of the drug; there was no consistent mode of presentation or latency period. The 56-week completion rate was 72% for liraglutide and 64% for placebo. The most common adverse events for liraglutide were gastrointestinal (i.e. nausea, diarrhea, and constipation). People generally began to feel nauseous during weeks 1–4, the nausea was usually mild or moderate, and the feeling tended to diminish over time. Given the findings of alreadypublished cardiovascular outcomes trials, including the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) cardiovascular outcomes trial (CVOT), there has been some concern regarding the safety of AstraZeneca’s (London, United

© 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd

Manu V. Venkat and Kelly L. Close are of Close Concerns (, 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 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@


Diabetes News

Journal of Diabetes NEWS

Kingdom) dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin.1 Dr Robert Frederich (Bristol-Myers Squibb, Princeton, NJ, USA) presented the results of a post-hoc metaanalysis of 20 phase IIb and IIIb trials of saxagliptin, excluding the SAVOR-TIMI 53 cardiovascular outcomes trial. The 9156 patients included in the 20-trial pool could be seen as more representative of the type 2 diabetes patient population than patients enrolled in SAVOR, and were (on average) younger, had lower diabetes duration (45–49% less than 3 years), and at much lower CV risk at baseline. As a result, the event rate for MACE (the primary outcome in both SAVOR and this meta-analysis) was approximately three-fold higher in SAVOR than in the 20-study pool. The meta-analysis of the full 20-study pool found a MACE incidence rate ratio (IRR) of 0.74 trending in favor of saxagliptin, although it was not statistically significant (95% CI: 0.45–1.25). Subanalyses by individual components of MACE were also not statistically significant but may have trended slightly in favor of saxagliptin. Notably, heart failure (which was not a component of the primary MACE endpoint but was also analyzed) trended more strongly towards saxagliptin (IRR = 0.55; 95% CI: 0.27–1.12), although heart failure was not adjudicated in these 20 studies as it was in SAVOR. Dr Nitesh Kuhadiya (University of Buffalo, Buffalo, NY, USA) presented data from the first prospective, randomized, double-blind, placebo controlled clinical trial of 390

liraglutide in type 1 diabetes. Patients (n = 72) in the 12-week study were randomized to placebo or one of three liraglutide doses (0.6, 1.2, or 1.8 mg). The 1.2 and 1.8 mg doses yielded reductions in A1c (declines of 0.4% and 0.7% from baselines of 7.4% and 7.8%, respectively). The high dose of the drug also yielded benefits in total insulin dose (approximately a 19% reduction), body weight (approximately a 5% reduction), daily carb intake (approximately a 28% reduction), and even C-reactive protein, a marker of inflammation (a reduction of approximately 17%). In addition to data on diabetes drugs, there were also presentations on diabetes technology. Dr Scott Lee shared new data from a 48-patient home study of the Medtronic (Northridge, CA, USA) MiniMed Duo, a 3-day wear combined insulin infusion-CGM sensor set. Patients wore five MiniMed Duo devices during the 15-day study and sensor accuracy was compared to self monitoring of blood glucose (SMBG) values. The sensor’s overall mean absolute relative difference (MARD) was 15.5% and 77% of points fell in Zone A of the Consensus Error Grid (n = 5056 paired points). There were 44 total adverse events, with 98% classified as mild in severity and skinrelated (e.g., “bruising and bleeding”); one patient had an abscess that was treated with antibiotics. Dr George Grunberger presented the results from a 12-month observational study of Valeritas’ (Bridgewater, NJ, USA) V-Go disposable insulin patch pump. This poster pre-

sented 6-month interim data from 40 patients with type 2 diabetes who switched to V-Go therapy from baseline treatment with long-acting insulin. At the study midpoint, patients experienced significantly improved A1c levels in all dosage groups (an overall 1% decline from an 8.9% baseline) and a reduction in total daily insulin dose in the V-Go 30 and V-Go 40 dosage groups. Only five hypoglycemic events

American Association of Clinical Endocrinologists 23rd Annual Scientific and Clinical Congress (AACE 2014).

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