Liraglutide in Children and Adolescents with Type 2 Diabetes

  • Tamborlane W
  • Barrientos-Pérez M
  • Fainberg U
  • et al.
248Citations
Citations of this article
460Readers
Mendeley users who have this article in their library.

Abstract

© 2019 Massachusetts Medical Society. BACKGROUND Metformin is the regulatory-approved treatment of choice for most youth with type 2 diabetes early in the disease. However, early loss of glycemic control has been observed with metformin monotherapy. Whether liraglutide added to metformin (with or without basal insulin treatment) is safe and effective in youth with type 2 diabetes is unknown. METHODS Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio, to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period, followed by a 26-week open-label extension period. Inclusion criteria were a body-mass index greater than the 85th percentile and a glycated hemoglobin level between 7.0 and 11.0% if the patients were being treated with diet and exercise alone or between 6.5 and 11.0% if they were being treated with metformin (with or without insulin). All the patients received metformin during the trial. The primary end point was the change from baseline in the glycated hemoglobin level after 26 weeks. Secondary end points included the change in fasting plasma glucose level. Safety was assessed throughout the course of the trial. RESULTS Of 135 patients who underwent randomization, 134 received at least one dose of liraglutide (66 patients) or placebo (68 patients). Demographic characteristics were similar in the two groups (mean age, 14.6 years). At the 26-week analysis of the primary efficacy end point, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of-1.06 percentage points (P<0.001); the difference increased to-1.30 percentage points by 52 weeks. The fasting plasma glucose level had decreased at both time points in the liraglutide group but had increased in the placebo group. The number of patients who reported adverse events was similar in the two groups (56 [84.8%] with liraglutide and 55 [80.9%] with placebo), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide. CONCLUSIONS In children and adolescents with type 2 diabetes, liraglutide, at a dose of up to 1.8 mg per day (added to metformin, with or without basal insulin), was efficacious in improving glycemic control over 52 weeks. This efficacy came at the cost of an increased frequency of gastrointestinal adverse events. (Funded by Novo Nordisk; Ellipse ClinicalTrials.gov number, NCT01541215.).

References Powered by Scopus

Statistical analysis with missing data

13950Citations
N/AReaders
Get full text

Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: A systematic analysis for the Global Burden of Disease Study 2013

9325Citations
N/AReaders
Get full text

Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the european association for the study of diabetes (EASD)

2074Citations
N/AReaders
Get full text

Cited by Powered by Scopus

Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity

650Citations
N/AReaders
Get full text

American Association of Clinical Endocrinology Clinical Practice Guideline for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Primary Care and Endocrinology Clinical Settings: Co-Sponsored by the American Association for the Study of Liver Diseases (AASLD)

564Citations
N/AReaders
Get full text

Long-term complications in youth-onset type 2 diabetes

308Citations
N/AReaders
Get full text

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Cite

CITATION STYLE

APA

Tamborlane, W. V., Barrientos-Pérez, M., Fainberg, U., Frimer-Larsen, H., Hafez, M., Hale, P. M., … Barrett, T. (2019). Liraglutide in Children and Adolescents with Type 2 Diabetes. New England Journal of Medicine, 381(7), 637–646. https://doi.org/10.1056/nejmoa1903822

Readers over time

‘19‘20‘21‘22‘23‘24‘250306090120

Readers' Seniority

Tooltip

PhD / Post grad / Masters / Doc 104

60%

Researcher 44

25%

Professor / Associate Prof. 16

9%

Lecturer / Post doc 10

6%

Readers' Discipline

Tooltip

Medicine and Dentistry 131

67%

Pharmacology, Toxicology and Pharmaceut... 28

14%

Nursing and Health Professions 25

13%

Biochemistry, Genetics and Molecular Bi... 12

6%

Article Metrics

Tooltip
Mentions
News Mentions: 30

Save time finding and organizing research with Mendeley

Sign up for free
0