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Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

Results from 10 major clinical trials on prevention and management of type 2 diabetes featured prominently at the American Diabetes Association (ADA) 2019 Scientific Sessions, held June 7 through June 11 in San Francisco, California. "The hottest clinical areas in diabetes have to do with the potential cardiovascular (CV) and renal outcomes for some of the newer agents, especially the sodium-glucose cotransporter type 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor (GLP-1) agonists," said program chair Jose C. Florez, MD, PhD, professor of medicine at Harvard Medical School, Boston, Massachusetts. "Some of these trials will have a major impact on how we" practice medicine, added ADA Science and Medicine President Louis H. Philipson, MD, PhD, director of the Kovler Diabetes Center, University of Chicago, Illinois. There was also a remarkable advance in type 1 diabetes, as well as good news on the automated insulin delivery front.

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

Among the highlights this year:

  • Investigational anti-CD3 monoclonal antibody delays type 1 diabetes onset
  • Troubling contrasting findings from adult and adolescent RISE studies
  • 'Alarming' complications in 20 year olds with type 2 diabetes in TODAY-2
  • Oral semaglutide effective but will it live up to promise in real world?
  • Once-weekly dulaglutide benefit in longest CV outcomes trial to date
  • Reassuring data on CV safety for linagliptin, glimepiride in type 2 diabetes
  • CREDENCE 'knocks your socks off': New analysis reported at ADA

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

Game Changer: Antibody First to Delay Type 1 Diabetes Onset in TrialNet

For the first time, the onset of type 1 diabetes has been successfully delayed in those at high risk using teplizumab, an investigational anti-CD3 monoclonal antibody (Provention Bio). The biologic modifies CD8+ T lymphocytes, which are thought to be involved in beta-cell destruction. Lead investigator Kevan Herold, MD, from Yale University, New Haven, Connecticut, presented results of the phase 2, randomized, placebo-controlled trial of teplizumab in 76 pediatric and adult high-risk relatives of patients with type 1 diabetes. All of them had two or more autoantibodies and subclinical abnormal glucose tolerance. Teplizumab infusions for 14 days delayed the development of type 1 diabetes by 2 years compared to placebo, without major adverse events. The results are game changing, Herold said during a press briefing held at the meeting. "I think this changes the way we've thought about this in the past," he said. "There's been some reluctance on the part of families to engage in this sort of screening, to be identified [as high-risk], because the question has been, 'What do you do about it?' Now, we can say there's something we can do about it."

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

'Like Watching a Car Crash in Slow Motion': New RISE Data

Contrasting findings of the Restoring Insulin Secretion (RISE) adult medication study with those of the same trial in adolescents show just how dreadful the prognosis is for youth with type 2 diabetes. Results of the adult RISE study show that those with prediabetes or new-onset diabetes who received treatment had improvements in beta-cell function during the year of the study compared with those on placebo. Yet in RISE in adolescents, reported last year, early treatment in teens with prediabetes or recent-onset type 2 diabetes for a year failed to prevent deterioration in beta-cell function. "In adults, we see an improvement," but, "there was no sustained improvement in beta-cell function in youth [representing] a troublesome set of data," said RISE investigator Steven E. Kahn, MBChB, University of Washington, Seattle. "These youngsters have burned out their residual beta cells. There is very little to work with. Despite treatment, the kids were progressing. This is scary," he said. Indeed, fellow RISE investigator Kieren J. Mather, MD, Indiana University School of Medicine, Indianapolis, said observing type 2 diabetes in youth is "like watching a car crash in slow motion."

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

'Alarming' Complications in 20-Year-Olds With Type 2 Diabetes

Young people diagnosed with type 2 diabetes in their early teens had an "alarming" high rate of diabetes-associated complications by the time they hit their mid-20s in the Longitudinal Outcomes in Youth With Type 2 Diabetes (TODAY-2) study. Among more than 500 young people in the study, five died of various causes, mostly related to their diabetes within about 7.5 years of diagnosis. "CV risk factors are highly prevalent in the population, target organ damage is evident, and serious CV events are occurring at rates unexpected for age [around mid-20s]," said lead investigator Philip S. Zeitler, MD, PhD, from University of Colorado School of Medicine, Aurora. In addition, a number of the girls subsequently became pregnant and pregnancy complications and neonatal morbidity were high. "The bottom line," said Zeitler, "is that many of these kids have a very rapid course both in terms of loss of glycemic control as well as development of complications. I think we need to recognize that, in fact, in these younger kids we probably need even more aggressive management than many adults with type 2 diabetes."

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

PIONEER 6: Will Oral Semaglutide Live Up to Promise in Real World?

An investigational oral version of the GLP-1 agonist semaglutide (Novo Nordisk) is safe in patients with type 2 diabetes at high CV risk, with a nonsignificant 21% reduction in major adverse cardiac events (MACE), the results of PIONEER 6 show. Oral semaglutide is "wildly effective, it is reasonably well-tolerated and similar to liraglutide in the head-to-head study of the GLP-1 receptor agonist class," said principal investigator John Buse, MD, of the University of North Carolina School of Medicine, Chapel Hill. "Oral semaglutide is arguably the most effective glucose-lowering, weight loss-promoting drug full stop, except perhaps subcutaneous semaglutide (Ozempic)," he told conference attendees. Oral semaglutide is currently under review by drug regulators in the United States, Europe, and Canada. "If approved, oral semaglutide will be the first formulation of a GLP-1 receptor agonist in a tablet."

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

Once-Weekly Dulaglutide Benefit in REWIND, Longest CVOT to Date

The once-weekly injectable GLP-1 agonist dulaglutide (Trulicity, Lilly) for type 2 diabetes significantly reduced the risk of MACE in the REWIND CV outcomes trial, primarily by reducing the risk of stroke. "The REWIND trial was an ambitious study that conclusively assessed the effects of dulaglutide on people with type 2 diabetes both with and without prior cardiovascular disease (CVD)," said study chair Hertzel Gerstein, MD, of McMaster University, Hamilton, Ontario, Canada. "The reduction in CV events observed in a wide range of people with diabetes regardless of sex, baseline CVD, age, or HbA1c level is compelling," he added. Dulaglutide was also found to modestly reduce weight by around 1.5 kg (P = .0001) and systolic blood pressure by 1.7 mmHg (P = .0001). After top-line results were released late last year, the full data were presented by Gerstein and simultaneously published in the Lancet, alongside an exploratory analysis on renal outcomes.

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

Type 2 Diabetes Message 'Has Got to Be Trashed,' Says DiRECT Author

Diabetologists in recent years have been forewarning people with newly diagnosed type 2 diabetes they have a progressive condition that will eventually require insulin therapy. But one expert believes his latest research supports a different approach. "We can say, 'If you stay your current weight, or even put on weight as some people do, you will follow the track of slowly going downhill," said Roy Taylor, MB, of Newcastle University, Newcastle upon Tyne, UK. "And don't worry, we can look after you and give you pills, but we're going to be supervising your demise. So that's one choice. On the other hand, you might want to do this, admittedly, challenging thing and escape." The path to that "escape" is weight loss, pure and simple, said Taylor. And although that message may not seem new, tying it to the potential for diabetes remission makes it more enticing, he noted, pointing to the "extraordinary" 28% response rate he and his UK team got to recruiting letters for the Diabetes Remission Clinical Trial (DiRECT). The study found rapid weight loss that is maintained can lead to remission of type 2 diabetes at 2 years in patients with early disease. "There is a possible way back even after type 2 diabetes has been diagnosed. This is very good news for people with diabetes," said Taylor.

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

D2d: Vitamin D Doesn't Stop Diabetes in Those With Prediabetes

Vitamin D3 supplementation in people at high risk of developing diabetes but who did not have vitamin D insufficiency does not reduce the chances of developing the disease compared with placebo, according to findings from the randomized, placebo-controlled Vitamin D and Type 2 Diabetes (D2d) trial, presented by Anastassios Pittas, MD, from Tufts Medical Center, Boston, Massachusetts. "Our study results did not show a statistically significant benefit for vitamin D in decreasing progression to type 2 diabetes in people who have sufficient levels," he said. However, in a post-hoc analysis, vitamin D supplementation "potentially had a benefit in those with very low vitamin D levels (20% of the study population was deemed at least vitamin D 'insufficient' as opposed to the remainder who were vitamin D sufficient)," he said. After 2.5 years of follow-up of over 99% of the participants, no significant difference was found in the development of diabetes between those taking vitamin D supplementation and those on placebo (P = .12).

Photo courtesy of Alanna Weisman/Twitter

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

'Mix and Match' Options Emerging in Automated Insulin Delivery

As automated insulin delivery is rapidly evolving, interchangeability between insulin pumps and sensors on the various platforms is emerging as a key component to moving the field forward. Medtronic will be working with the nonprofit Tidepool to create an interoperable automated insulin pump system, a category the US Food and Drug Administration now calls "alternate controller enabled" pumps. Tidepool is a data hub for patients and clinicians to combine and view data from insulin pumps, continuous glucose monitors, and blood glucose meters. As a next step, the organization is now developing the Tidepool Loop app, which would serve as a platform allowing interoperability between various diabetes devices. "Interchangeability is a big issue...I think patients would like to be able to mix and match and choose the devices that work best for them," said Alanna Weisman, MD, from University of Toronto, Ontario, Canada, who moderated an oral abstract session on automated insulin delivery. Weisman said she was surprised by the Medtronic announcement, but that "it's very exciting."

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

High BP and HbA1c: Similar Risks for CVD in Youth With Type 1 Diabetes

Controlling blood pressure (BP) is as important as keeping glucose in check when it comes to the prevention of CV events in young people with type 1 diabetes, say researchers, who found that CV risk doubles if BP levels hit 120/80 mmHg or higher. The analysis was based on 605 participants in the Pittsburgh Epidemiology of Diabetes Complications (EDC) study, which enrolled patients with type 1 diabetes diagnosed at age 17 years or younger. "We see that the high [BP] group and the high HbA1c group present a similar risk for heart disease in this high-risk population," said Jingchuan Guo, MD, PhD, of the University of Pittsburgh, Pennsylvania. "Since [BP] control is likely to be as important as glucose control for CV risk prevention in people with type 1 diabetes, the initial treatment focus should be on glucose control, when HbA1c is very high, but as HbA1c approaches the high-normal range, an increasing focus on [BP] becomes critical," she said.

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

CAROLINA Reassures on CV Safety for Linagliptin, Glimepiride in Type 2 Diabetes

There were no major differences in CV outcomes between the dipeptidyl peptidase 4 (DPP-4) inhibitor linagliptin (Tradjenta, Boehringer Ingelheim/Lilly) and the sulfonylurea glimepiride (Amaryl, Sanofi) in patients with early type 2 diabetes at increased CV risk in the Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (CAROLINA) presented by Julio Rosenstock, MD, director of the Dallas Diabetes Research Center at Medical City, Texas, and coauthors. The new findings don't change current treatment recommendations for use of a type 2 diabetes agent with proven CV benefit — a sodium-glucose cotransporter type 2 (SGLT2) inhibitor or a GLP-1 agonist — after metformin in patients with CVD. But for other patients with type 2 diabetes, they do inform the choice of a second-line agent when cost is an issue, said Rosenstock. "Other than a cost consideration, CAROLINA supports the use of a DPP-4 inhibitor (linagliptin) before a sulfonylurea (glimepiride)," he said, adding that, at the same time, CV safety "should no longer be a consideration in the decision-making process for selecting between either of these two oral agents."

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

CREDENCE 'Knocks Your Socks Off': New Analysis Reported at ADA

A deeper dive into the Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation (CREDENCE) renal outcomes trial found that the SGLT2 inhibitor (Invokana, Janssen) reduces the risk of cardiac and renal events, even in patients without prior CVD (primary prevention group) in patients with type 2 diabetes and chronic kidney disease (CKD). After a median follow-up of 2.5 years, the "landmark" trial was stopped early due to a 30% lower rate of the primary composite outcome (a doubling of serum creatinine, end-stage kidney disease [requiring dialysis or a kidney transplant], renal death, or CV death) in patients who received canagliflozin versus placebo added to standard care. The new analysis presented shows that in these patients with type 2 diabetes and CKD, canagliflozin provided "consistent and robust reductions in the risk of renal and CV outcomes in both primary and secondary prevention populations," said Meg Jardine, MBBS, PhD, University of New South Wales, Sydney, Australia. "This is the first study to show a benefit in" major outcomes in people with diabetes and CKD who have never had a prior CV event, she noted.

Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

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Top News From ADA 2019: Slideshow

Lisa Nainggolan; Darby Rotach; Marlene Busko; Becky McCall; Miriam Tucker; Megan Brooks | June 25, 2019 | Contributor Information

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