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ClINICAl TrIAl HIGHlIGHTS placebo responders (69.2% vs 44.4%, respectively) than in liraglutide and placebo nonresponders (67.2% vs 39.6%, respectively). Responders had lower rates of AEs leading to withdrawal (liraglutide, 4.5%; placebo, 0.9%). In nonresponders, the figures were 17% for liraglutide vs 4.8% for placebo. Liraglutide responders had greater improvements than nonresponders across a range of efficacy outcomes. Overall, weight loss ≥ 5% was achieved in a higher proportion of patients on liraglutide, 3 mg, with a stronger effect among responders. The rates of AEs were largely equivalent in responders and nonresponders. A mean weight loss of 11.7% was achieved by patients who were overweight or obese without diabetes and responded to liraglutide. The weight loss responders in both treatment groups also had improved glycemic, cardiometabolic, and health-related quality-of-life outcomes. The SCALE-Obesity and Prediabetes trial showed that liraglutide is a safe and effective weight loss option in the study population. Significant HbA1c Reduction With Empagliflozin/ Linagliptin Combination Written by Rita Buckley One tablet of empagliflozin and linagliptin significantly reduced HbA1c in patients with type 2 diabetes. Andrew J. Lewin, MD, National Research Institute, Los Angeles, California, USA, and colleagues conducted a randomized, double-blind, parallel-group, phase 3 study, the Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes study [Lewin A et al. Diabetes Care. 2015]. Empagliflozin reduces renal glucose reabsorption, thereby increasing urinary glucose excretion. This leads to a decline in plasma glucose levels in an insulin-independent manner [Heise T et  al. Diabetes Obes Metab. 2013]. Linagliptin prevents the inactivation of incretin peptides, such as glucagon-like peptide-1 (GLP-1), stimulates insulin release, and inhibits glucagon secretion [Gallwitz B. Diabetes Metab Syndr Obes. 2013]. Each drug is an FDA-approved treatment for patients with type 2 diabetes. As compared with the single agent treatment groups, those treated with the dual combination achieved lower A1c levels. Efficacy was evaluated in 667 patients who had not received antihyperglycemic therapy for ≥ 12 weeks. Their mean (standard deviation) age was 54.6 (10.2) years; mean weight was 87.9 (20.1) kg; average body mass index was 31.6 (5.6) kg/m2; and mean HbA1c level was 8.02% 14 May 2015 (0.96). Baseline characteristics were balanced between treatment groups. Patients were randomized (1:1:1:1:1) to receive empagliflozin 25 mg/linagliptin 5 mg as a fixed-dose combination (FDC) tablet; empagliflozin 10 mg/linagliptin 5 mg as an FDC tablet; empagliflozin 25 mg; empagliflozin 10 mg; or linagliptin 5 mg for 52 weeks. The primary end point was the change from baseline in HbA1c at week 24. At week 24, reductions from baseline in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < .001), but not compared with empagliflozin 25 mg (P < .179), and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with individual doses (P < .001 for both). At week 24, 55.4% of patients with baseline HbA1c ≥ 7% reached HbA1c < 7% with empagliflozin 25 mg/linagliptin 5 mg; 62.3% did so with empagliflozin 10 mg/linagliptin 5 mg; 41.5% with empagliflozin 25 mg; 38.8% with empagliflozin 10 mg; and 32.3% with linagliptin 5 mg. Efficacy was maintained at week 52. The proportion of patients with adverse events over this time was similar across groups (68.9% to 81.5%), with no confirmed hypoglycemic adverse events in either combination group. Empagliflozin/linagliptin was welltolerated, with an overall safety profile similar to those of the individual drugs. This was the first randomized controlled trial to evaluate the efficacy and safety of the initial combination of a sodium-glucose cotransporter 2 (SGLT2) inhibitor (empagliflozin) and a DPP-4 inhibitor (linagliptin) in patients with type 2 diabetes. ATL1103 Effective in Reducing IGF-1 Levels in Patients With Acromegaly Written by Jill Shuman Acromegaly is a chronic disorder resulting from excessive secretion of growth hormone, with a resulting increase in the production of the hormone known as insulinlike growth factor 1 (IGF-1). ATL1103 is a second-generation antisense drug designed to silence growth hormone receptor expression, thereby reducing levels of IGF-1 in the blood. It is currently under investigation as a potential treatment for diseases associated with excessive growth hormone action, such as acromegaly [Störmann S, Schopohl J. Expert Opin Emerg Drugs. 2014]. Peter J. Trainer, MD, The Christie National Health Service Foundation Trust, Manchester, United Kingdom, reported primary efficacy results from the phase 2 clinical trial of ATL1103 in patients with acromegaly [2012-003147-30]. The ATL1103 phase 2 trial was a randomized, open-label, multicenter, parallel group study www.mdce.sagepub.com http://mdce.sagepub.com

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MD Conference Express - ENDO 2015

MD Conference Express - ENDO 2015 - (Page Cover1)
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