<i>Journal of Diabetes</i> NEWS

Journal of DiabetesVolume 5, Issue 1 p. 3-6 Journal of Diabetes NEWSFree Access Journal of Diabetes NEWS First published: 15 December 2012 https://doi.org/10.1111/1753-0407.12018 Nina A. Ran, Melissa Y. Tjota, 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 Ran, Tjota, 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). AboutSectionsPDF 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 Controversies to Consensus in Diabetes, Obesity, and Hypertension, Shanghai 2012 The 1st China Congress on Consen−sus in Diabetes, Obesity, and Hyper−tension (CODHy) was held 13–15 September 2012 at the Pudong Shangri-La hotel in Shanghai, China, with approximately 200 people in attendance. Dr Itamar Raz (Hadassah University Hospital, Jerusalem, Israel) opened the conference by speaking about the importance of the international exchange of knowledge and experience. Following up on his comments, Dr Ning Guang (Shanghai School of Medicine, Shanghai, China) aptly commented that although controversies exist in diabetes, obesity, and hypertension, it is only through controversy that we can eventually reach a consensus. This statement was highlighted in a debate between Dr Mu Yiming (General Hospital of the People's Liberation Army, Beijing, China) and Dr Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX, USA) on whether type 2 diabetes (T2D) should be prevented using lifestyle intervention or pharmacologic therapy. To begin the debate, Dr Mu affirmed his belief that lifestyle modification for people at high risk of developing diabetes was more important than pharmacologic intervention. He cited the Chinese Da Qing study,1 which demonstrated that lifestyle intervention would reduce progression from impaired glucose tolerance (IGT) to diabetes by 50%. The 20-year follow-up to the Da Qing study showed a reduction in the incidence of cardiovascular (CV) disease and mortality in the lifestyle intervention group. In contrast, Dr DeFronzo argued that healthcare providers should use drug therapy to prevent T2D because lifestyle intervention does not work on a long-term basis in real clinical settings. He presented data from an Australian study2 demonstrating that hormonal adaptations after weight loss promoted weight regain, perhaps explaining why it is so hard to keep weight off. In contrast, existing pharmacologic therapies have a higher efficacy in preventing progression from IGT to diabetes. In one study, 90% of people taking liraglutide (Novo Nordisk's Victoza) for 20 weeks reverted from IGT to normal glucose tolerance.3 Interestingly, during the Q&A discussion, it appeared that the Chinese audience generally favored lifestyle intervention over drug therapy for diabetes prevention, whereas US doctors tended to believe that achieving weight loss and maintenance in patients is extremely difficult. Another notable discussion discussed the fact that Asians typically exhibit a more rapid onset of diabetes compared with Caucasians, suggesting that drug trials conducted in largely Caucasian countries may not be applicable to the Asian population. Dr Ji Linong (Peking University People's Hospital, Beijing, China) argued that there is no convincing evidence demonstrating that Asians and Caucasians with T2D have different disease pathophysiologies. Dr Ji noted that meta-analyses of all currently available drug classes showed that diabetes drugs have the same, or even slightly greater, efficacy in Asians compared with Caucasians. Based on these data, Dr Ji argued that China did not need country-specific drugs to treat diabetes. He lightheartedly ended his talk by suggesting that one day China could start to develop novel drugs that Caucasian populations would then adopt, rather than the other way around. The last day of the meeting included a discussion on CV outcomes trials (CVOTs) and preventing CV complications in patients with diabetes. Dr DeFronzo spoke on the need to correct more than just hyperglycemia in order to reduce CV risk in diabetes patients, stating “…we can no longer live in a glucose centric world”. He argued that the three most effective actions to take in reducing cardiovascular risk were: (i) correction of dyslipidemia with statins (ii) blood pressure control with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers; and (iii) coronary artery bypass surgery for appropriate high-risk patients. Dr Lawrence Leiter (University of Toronto, Toronto, Canada) then discussed how the selection of endpoints for clinical trials could be improved. He highlighted that commonly used primary endpoints may be too broad or may not be clinically significant; thus, a positive or negative outcome for a study did not necessarily provide any clinically actionable information. He suggested that future trials be based on clinically meaningful and, ideally, standardized endpoints. Dr Itamar Raz (Hadassah University Hospital) ended the session by discussing why he believed CVOTs were necessary for diabetes drugs and how current CVOTs had improved over previous studies in the field. To conclude the conference, Dr Liu Chao (Chinese Society of Endocrinology) gave an enlightening talk on the Chinese Society of Endocrinology guidelines on the use of insulin secretagogues (sulfonylureas [SFUs] and glinides). He advocated strongly for their use, arguing that they are efficacious, durable, and particularly well suited to the Chinese population. Dr Liu characterized safety concerns over SFUs as “misunderstandings” and offered evidence to refute safety claims against SFUs. In the end, he argued that SFUs should be used as first line therapy, especially for those who cannot use metformin. If you are interested in receiving the full Close Concerns report on the CODHy Shanghai conference, please email Kelly Close (kelly.close@closeconcerns.com). References 1Pan X-R, Li G-W, Hu Y-H et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance: the Da Qing IGT and diabetes study. Diabetes Care. 1997; 20: 537– 44. CrossrefCASPubMedWeb of Science®Google Scholar 2Sumithran P, Prendergast L, Delbridge E et al. Long-term persistence of hormonal adaptions to weight loss. N Engl J Med. 2011; 365: 1597– 604. CrossrefCASPubMedWeb of Science®Google Scholar 3Astrup A, Carraro R, Finer N et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int. J. Obesity. 2012; 36: 843– 54. CrossrefCASPubMedWeb of Science®Google Scholar Company Updates August 31: Tandem Diabetes Care announced that it had started shipping its new t:slim insulin pump to patients. The pump's touchscreen user interface is designed to improve user experience and allow for easy training of new pump users. September 4: Medtronic announced that Bayer's Contour Next Link meter is available to patients ordering new Medtronic Paradigm Revel insulin pumps and Guardian Real-Time continuous glucose monitors (CGMs). September 10: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo launched the dipeptidyl peptidase (DPP)-4 inhibitor Tenelia (teneligliptin; 20 mg tablet) in Japan. Tenelia is the sixth DPP-4 inhibitor in Japan following Merck's sitagliptin (Januvia), Bristol-Myers Squibb/AstraZeneca's saxagliptin (Onglyza), Novartis’ vildagliptin (Galvus), Takeda's alogliptin (Nesina) and Lilly's linagliptin (Trazenta). September 18: Vivus announced the launch of the obesity drug Qsymia (phentermine/topiramate ER) in the US. The recommended dose (7.5 mg/46 mg) is priced at approximately US$5 per day. September 24: Novo Nordisk announced that it will invest an additional US$100 million to expand its new R&D facility in China, allowing the company to grow from 130 science employees to 200. Novo Nordisk currently has approximately 3000 employees in China. October 2: Roche launched the Accu-Chek Combo System, which integrates the Accu-Chek Spirit insulin pump with the Accu-Chek Aviva meter. As background, the product was cleared by the US Food and Drug Administration (FDA) in July 2012. The Accu-Chek Combo enters a very competitive wireless pump/meter market without major differentiators from Animas’ OneTouch Ping and Medtronic's Paradigm line, which are already established in the US. October 8: Dexcom announced that the US FDA had approved the G4 Platinum CGM and that it expects to begin shipping the product to patients during October. As a reminder, the CGM is already sold in several European countries. Compared with Dexcom's older Seven Plus CGM, the G4 Platinum provides 19% greater accuracy overall and 30% greater accuracy in hypoglycemia, and has a fourfold greater transmission range. October 9: Sanofi announced that it will launch a new reusable insulin pen called the AllStar in India in October. The pen will be manufactured in India and was developed for patients in emerging markets who are currently using insulin, as well as for insulin naïve patients. October 8: Hygieia announced that it has received Conformite Europeene (CE) Mark approval for the d-Nav system, which integrates a blood glucose sensor into Hygieia's Diabetes Insulin Guidance System. A patient would use d-Nav before each injection by placing a test strip into the device, applying blood, and following the insulin dose recommendation advised by the system. Although a healthcare provider would enter the initial basal, premixed, or basal-bolus settings, the d-Nav system would automatically refine these settings over time based on glucose patterns. October 15: The USA FDA granted clearance for Roche's Accu-Chek Inform II blood glucose meter, which is used in hospitals. The product wirelessly transfers patients’ data to hospital information systems, and Roche expects to launch the product later this year. October 18: Reata and Abbott announced that they have terminated the Phase 3 BEACON trial for bardoxolone methyl, an investigational drug for chronic kidney disease. They trial was ended abruptly owing to an excess of serious adverse events and deaths in the bardoxolone arm. The companies have not provided details as to whether or how they will proceed with the drug's development. October 18: Vivus announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended against approval of the obesity drug Qsiva (branded as Qsymia in the US). Vivus noted that the CHMP expressed concern over the drug's teratogenic potential, its long-term impacts on the CV and central nervous systems, and the possibility of poor patient selection. Vivus intends to appeal this decision. October 19: The National Institutes of Health (NIH) announced an early stop to the Look AHEAD trial, which compared the effects of intensive lifestyle intervention (ILI) with those of diabetes support and education (DSE) on CV events. The NIH terminated the ILI arm of the trial ahead of schedule owing to a low likelihood that the ILI regimen would lower CV risk compared with DSE. October 22: Eli Lilly reported positive top-line results from three Phase 3 studies of its once-weekly glucagon-like peptide-1 (GLP-1) agonist dulaglutide. In the three trials (AWARD 1, AWARD 3, and AWARD 5), dulaglutide 1.5 mg demonstrated superior HbA1c reduction compared with placebo at 26 weeks, and non-inferior HbA1c reductions versus metformin at 26 weeks and sitagliptin (Januvia) at 52 weeks. The same three studies showed that dulaglutide 0.75 mg and 1.5 mg provided greater HbA1c reductions than exenatide (Byetta) at 26 weeks, metformin at 26 weeks, and sitagliptin (Januvia) at 52 weeks. October 24: Bristol-Myers Squibb announced that it and diabetes partner AstraZeneca will resubmit the sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Forxiga) to the US FDA in the middle of 2013. As a reminder, dapa gliflozin received a complete response letter from the US FDA in January 2012, likely due to the agency's concerns regarding the drug's potential risk for breast and bladder cancer. October 25: C8 MediSensors announced that it received CE Mark approval for its non-invasive optical CGM, allowing it to be marketed in Europe. November 8: The US FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted eight to four in favor of approving Novo Nordisk's insulin degludec and insulin degludec/aspart. The EMDAC also voted unanimously to require Novo Nordisk to perform a CV outcomes trial. November 14: Bristol-Myers Squibb and diabetes partner AstraZeneca announced that the European Commission has approved the SGLT-2 inhibitor dapagliflozin (Forxiga) for the treatment of T2D in combination with glucose-lowering drugs or as monotherapy in metformin-intolerant patients. The decision will likely make Forxiga the first SGLT-2 inhibitor on the global market. November 9: The US FDA published its finalized guidance on the artificial pancreas on its website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdf, accessed 14 November 2012). The document outlines the agency's expectations regarding the development of the artificial pancreas, and highlights its willingness to collaborate with sponsors. November 16: Sanofi announced that its once-daily GLP-1 agonist Lyxumia (lixisenatide) has received a recommendation for approval in the European Union from the EMA's CHMP. Sanofi now expects a final decision from the European Commission in 2–3 months. If approved, Lyxumia will be the fourth GLP-1 agonist on the global market behind Bristol-Myers Squibb/AstraZeneca's Byetta (exenatide twice daily) and Bydureon (exenatide once weekly), and Novo Nordisk's Victoza (liraglutide). Volume5, Issue1March 2013Pages 3-6 ReferencesRelatedInformation

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