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Highlights from the 18th American Diabetes Association meeting (ADA), Orlando, USA, June 22–27th 2018

Highlights from the 18th American Diabetes Association meeting (ADA), Orlando, USA, June 22–27th 2018
  • Endocrinology and metabolism
  • Diabetes

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Article

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International meeting
Diabetes
SGLT2 Inhibitors
RISE study
adolescent type 2 diabetes

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Practical

Highlights from the ADA this year included results from new trials in type 1 and type 2 diabetes, and presentation of the draft revised ADA/EASD consensus report on hyperglycemia management in type 2 diabetes.


While not approved by the US Food and Drug Administration for type 1 
diabetes (T1D), off-label use of sodium-glucose co-transporter 2 
(SGLT2) inhibitors continues to increase. Professor Ele Ferrannini (Pisa, Italy) reviewed the metabolic effects of SGLT inhibition in T1D. Research has shown positive patient outcomes with this class of drug, including reductions in A1C, body weight, fasting glucose, blood pressure and insulin doses, along with improvements in quality of life. But research has also shown an increased risk of diabetic ketoacidosis (DKA). The development of DKA in patients undergoing SGLT2 treatment follows the primary mechanism of action and classic metabolic pathway that leads to DKA, with the exception that DKA in patients on SGLT2 inhibitors may not have as high glucose levels as in classic DKA because of the glycosuria.

Professor John B. Buse (University of North Carolina School of Medicine, USA) discussed a development program to support regulatory approval of sotagliflozin, a novel dual inhibitor of SGLT1 and SGLT2. Results reported during 2017 from the Tandem3 trial1 (a phase 3
 study to evaluate the safety of sotagliflozin in patients with T1D who have inadequate glycemic control with insulin therapy alone) together with Tandem1 and Tandem2 (unpublished) indicate that sotagliflozin provided a moderate but significant reduction in A1C, body weight and blood pressure, along with small reductions in insulin dosages - but increased the risk for DKA.

Professor Paresh Dandona (State University of New York, USA) discussed the clinical efficacy and safety of dapagliflozin in T1D patients – a drug that has reported similar results to sotagliflozin. Interestingly, Professor Julio Rosenstock (Dallas Diabetes Research Center, USA) showed preliminary results of the SGLT2 inhibitor empagliflozin 2.5 mg in T1D that does not increase the incidence of DKA compared with placebo. The full results of this study will be presented at EASD in Berlin in October 2018.

The results of the ‘Restoring Insulin Secretion (RISE) Study2 were presented by Professor Kristen J. Nadeau (University of Colorado Anschutz Medical Campus, USA). In total, 91 adolescents who had impaired glucose tolerance (80.3%) or type 2 diabetes (T2D) for <6 months (19.7%) were randomly assigned to receive either 12 months of metformin or 3 months of the insulin glargine followed by 9 months of metformin. After 12 months, medications were discontinued for a 3-month washout period. Beta-cell function at baseline, after 12 months and after 15 months (the end of the washout period) was assessed by hyperglycemic clamp. At 6 months, HbA1c levels were reduced transiently from baseline in both groups, but this was not sustained at 12 months. At 12 and 15 months, beta-cell function was significantly worse than at baseline. Thus, despite early phase intervention in adolescents who had impaired glucose tolerance or who were recently diagnosed with T2D, the beta-cell dysfunction progressed and was worse than at baseline, showing no positive impact of early therapy. These findings contrast with those published in adults that show an improvement in beta-cell function both with metformin and with insulin for diabetes prevention and treatment. Since metformin and insulin are currently the only FDA-approved therapies for youth with T2D, it is now important to understand why adolescent diabetes is more aggressive and how it should be treated.

The new draft ADA/EASD Consensus Report 2018 on managing hyperglycemia in T2D, the third such joint consensus statement from the two groups, was released at this meeting. The initial statement was issued in 2012 and revised in 2015. A second round of revisions will be made this summer based on comments and feedback from diabetes care providers, clinical researchers, patient groups, payers, regulators and stakeholders. The final draft of the new statement will be released in October 2018 at the EASD annual meeting in Berlin, Germany. Professor Deborah J. Wexler (Harvard Medical School, USA) reported that a major shift for this report is the need to consider the patient’s important comorbidities, particularly cardiovascular disease or high cardiovascular risk, in selecting glucose-lowering therapy. Professor John B. Buse emphasized that this guideline was particularly impressive and rich as it was the result of input from multiple academic clinicians from the United States and Europe, from various disciplines, focused on obesity, diabetes and primary care.         

References

  1. Garg SK, et al. N Engl J Med 2017 Dec14;377(24):2337-2348.

  2. The RISE Consortium. Diabetes Care 2018 Jun 25.

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