OFFICIAL HIGHLIGHTS

American Diabetes Association

Conference summaries


THERAPEUTICS

Longitudinal Outcomes in Youth with Type 2 Diabetes—The TODAY2 Study

Presented by: Kimberly L. Drews, MD, PhD
George Washington University, DC, USA
Lorraine E. Levy Katz, MD
Children’s Hospital of Philadelphia, PA, USA
Petter Bjornstad, MD
University of Colorado, CO, USA
Neil H. White, MD
Washington University in St. Louis, LA, USA
Jeanie B. Tryggestad, MD
University of Oklahoma, OK, USA
Ruth S. Weinstock, MD, PhD
SUNY Upstate Medical University, NY, USA
for the TODAY2 Study Group
  • The TODAY study found that type 2 diabetes in youth is a more aggressive disorder than in adults, with higher medication failure, more rapid b-cell decline, and accelerated appearance of complications.
  • TODAY2 is a post-intervention follow-up study of TODAY with the primary objective of monitoring progression of type 2 diabetes and complications as individuals transition to young adulthood.

The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) Study was the first multiethnic, multicenter, randomized trial examining youth-onset type 2 diabetes (Y-T2D). TODAY2 is a follow-up study that tracked the progression of type 2 diabetes and related comorbidities and complications as the participants transition to young adulthood. Data from this cohort allows better understanding on the development of renal, cardiac, eye, and nervous system complications, as well as data on pregnancy outcomes and health care utilization in this vulnerable population.

  • Post-intervention follow-up of the TODAY cohort.

Type of study, patients, and inclusion criteria

  • Eligible patients in the TODAY trial were 10 to 17 years of age and treated with metformin (at a dose of 1,000 mg twice daily) to attain a HbA1c level <8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle intervention program focusing on weight loss through eating and activity behaviors.

Patient population

  • Total number of enrollees: 517 patients in phase 2 of the follow-up.
  • Mean age 21.2 years, mean HbA1c of 9.3%, and mean BMI of 36.3 kg/m2.
  • Mean of 6.9 years since diagnosis.

Outcomes

  • Cardiac, renal, eye, and nervous system complications were recorded, as well as data on pregnancy outcomes and health care utilization.

Cardiovascular complications

  • The cumulative incidence of dyslipidemia and hypertension increased over 12 years.
  • Adolescents with T2D had increased left ventricular mass/height (g/m2.7), left ventricular ejection fraction (%), and left atrial internal dimension.
  • Cardiac remodeling was evident in young adults with obesity and T2D.

Renal complications

  • During TODAY and TODAY 2, the 12-year cumulative incidence was 40% for elevated urinary albumin and 48% for hyperfiltration.
  • 13.8% of participants had a rapid decline in eGFR.
  • Loss of glycemic control was an important risk factor for development of diabetic kidney disease, together with race/ethnicity and sex.

Retinopathy

  • Advanced diabetic retinopathy requiring treatment was present in 9% of the TODAY cohort.
  • Loss of glycemic control predicted progression of diabetic retinopathy.

Neuropathy

  • Diabetic neuropathy was present in 28-33% of the cohort by year 12.
  • The prevalence of diabetic neuropathy by monofilament rose to 8% by year 12.
  • Diabetic neuropathy was more prevalent in males.

Pregnancy outcomes

  • Maternal hypertension and nephropathy were higher than previously reported.
  • There was no difference in retinopathy in women who had a pregnancy vs. those who did not.
  • All fetal complications were higher than in previous reports, including macrosomia, large for gestational age, cardiac defects, and respiratory distress.

Health care utilization

  • There was a trend for uninsured participants to have poorer glycemic control, but HbA1c was high in all groups.
  • There was a trend for lower mean HbA1c in participants with commercial insurance
  • Of those insured, there was inadequate coverage for diabetes drugs (10%), supplies (20%), and monitoring (15%).
  • The burden of complications is accelerating as individuals with youth-onset type 2 diabetes transition to young adulthood.
  • Diabetes complications are common in this population and target organ damage is evident.
  • The high rates of maternal and fetal complications are of major concern.

Key Messages/Clinical Perspectives

  • Given the high rates of complications, aggressive management approaches are needed for youth-onset diabetes.
  • Youth with progressive diabetes have rapid loss of b-cell function.
  • There is a need to better understand the efficacy of pharmacological agents in this high-risk population.

 

Trial: NCT02310724



References

References


  1. The TODAY Study Group. A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes. N Engl J Med. 2012;366:2247-56.

Present disclosure: K.L. Drews, L.E. Levy Katz, P. Bjornstad, and J.B. Tryggestad: the presenters has reported that no relationships exist relevant to the contents of this presentation. N.H. White: Daiichi-Sankyo. R.S. Weinstock: Medtronic, Minimed, Diasome Pharmaceuticals, Oramed Ltd, Kowa research Inst., Boehringer Ingelheim, Eli Lilly, Insulogic LLC.

Written by: Patrick Moore, PhD

Reviewed by: Marco Gallo, MD


All report

Welcome to the ADA 2019 Highlights

Jose C. Florez, MD, PhD
Chair, ADA Scientific Sessions Meeting Planning Committee
The 79th American Diabetes Association’s Scientific Sessions were held in San Francisco, California from June 7-11, 2019. The meeting was attended by over 15,000 professional attendees from 115 countries, … [ Read all ]

CLINICAL TRIALS

Prevention

The Vitamin D and Type 2 Diabetes (D2d) Study—A Multicenter Randomized Controlled Trial for Diabetes Prevention

Presented by: Anastassios G. Pittas, MD; Erin S. LeBlanc, MD, MPH; Myrlene Staten, MD; for the D2d Research Group

Therapeutics

Longitudinal Outcomes in Youth with Type 2 Diabetes—The TODAY2 Study

Presented by: Kimberly L. Drews, MD, PhD; Lorraine E. Levy Katz, MD; Petter Bjornstad, MD; Neil H. White, MD; Jeanie B. Tryggestad, MD; Ruth S. Weinstock, MD, PhD; for the TODAY2 Study Group

Complications

Once-Weekly Dulaglutide and Major Cardiovascular Events—Results of the REWIND Trial

Presented by: Gilles R. Dagenais, MD; Rafael Diaz, MD; Matthew C. Riddle, MD; Hertzel C. Gerstein, MD, MSc; Helen Colhoun, MD; Jeffrey L. Probstfield, MD; Hertzel C. Gerstein, MD, MSc

Prevention

PREVIEW: PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World

Presented by: Ian Macdonald, MD; Edith Feskens, MD, MPH; Margriet Westerterp-Platenga, MD; Mathijs Drummen, MD

Obesity

Results and Comparisons from the RISE Clinical Trial—Adult Medication Study

Presented by: David A. Ehrmann, MD; Kieren J. Mater, MD; Sharon Edelstein, ScM; Steven E. Khan, MD, ChB; Thomas A. Buchanan, MD; Sonia Caprio, MD

Therapeutics

DECLARE-TIMI 58 Trial

Presented by: Itamar Raz, MD; Stephen D. Wiviott, MD; John P. Wilding, MD; Ofri Mosenzon, MD; Lawrence A. Leiter, MD

Therapeutics

The CAROLINA Trial—First Results of the Cardiovascular Outcomes Trial Comparing Linagliptin vs. Glimepiride

Presented by: Julio Rosenstock, MD; Mark A. Espeland, MD; Steven E. Kahn, MD; Nikolaus Marx, MD; Bernard Zinman, MD

Therapeutics

The CREDENCE Trial

Presented by: Rajiv Agarwal, MD; Meg J. Jardine, MD; Bruce Neal, MD; Kenneth W. Mahaffey, MD; Bernard Zinman, MD

Therapeutics

The CARMELINA Trial

Presented by: Steven E. Kahn, MD; Nikolaus Marx, MD; Darren K. McGuire, MD; Christoph Wanner, MD; Mark E. Cooper, MD

Therapeutics

Oral Semaglutide—The PIONEER Program Trials

Presented by: Vanita R. Aroda, MD; Richard E. Pratley, MD; Stephen C. Bain, MA, MD, FRCP; Mansoor Husain, MD, FRCPC; John B. Buse, MD, PhD; Vivian Fonseca, MD
 

CONSENSUS REPORT

Nutrition

ADA Nutrition Therapy for Adults with Diabetes—2019 Consensus Report

Presented by: Alison B. Evert, MD; Janice MacLeod, MA, RDN, CDE; William S. Yancy, Jr., MD, MHS; W. Timothy Garvey, MD; Ka Hei Karen Lau, MS, RD, LDN, CDE; Christopher D. Gardner, PhD; Kelly M. Rawlings, MS
 

SYMPOSIA

Complications

Cardiovascular and Renal Protection in Diabetes—Emphasis on SGLT2 Inhibitors and GLP-1 Receptor Agonists

Presented by: Julie A. Lovshin, MD, PhD; Jens J. Holst, MD, DMSc; David C. Wheeler, MD

Physiology/Obesity

Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH)—The Overlooked Complications of Type 2 Diabetes

Presented by: Elisabetta Bugianesi, MD, PhD; Zobair Younossi, MD, MPH; Kenneth Cusi, MD

Complications

Controversies in the Evaluation and Management of Dyslipidemia in Patients with Diabetes

Presented by: Amy Sanghavi Shah, MD, MS; Dan Streja, MD; Savitha Subramanian, MD; Lisa Tannock, MD

Complications

Hypoglycemia in Type 2 Diabetes

Presented by: Kamlesh Khunti, MD, PhD, FRCGP, FRCP; Elizabeth Selvin, PhD, MPH; Frans Pouwer, PhD; Sophia Zoungas, MBBS (Hons), PhD, FRACP