Last reviewed:September 2019
Last updated:September  2019
13 Sep 2019

FDA approves liraglutide for use in children ≥10 years with type 2 diabetes

The Food and Drug Administration (FDA) has expanded the use of liraglutide to include the treatment of children aged ≥10 years with type 2 diabetes.[76]

Liraglutide has been approved for use in adults since 2010, but the only approved treatment options available for younger children with type 2 diabetes were metformin or insulin. However, the TODAY study group determined that metformin monotherapy only provides durable glycemic control in around half of pediatric patients and that combination treatment or insulin therapy is required in most.[74]

The efficacy and safety of liraglutide for reducing blood sugar in pediatric patients with type 2 diabetes was studied in one placebo-controlled trial with 134 patients aged ≥10 years for more than 26 weeks. Approximately 64% of patients in the study had a reduction in their hemoglobin A1c (HbA1c) below 7% while on liraglutide, compared with only 37% who achieved these results with the placebo. All the patients also received metformin during the trial.[77]

Liraglutide is a glucagon-like peptide-1 (GLP-1) agonist, which acts to stimulate insulin and reduce glucagon secretion. As its action is glucose-dependent, insulin activity is triggered only in the presence of elevated blood glucose, which minimizes the risk of hypoglycemia. In adult populations, GLP-1 agonists induce weight loss and increase a feeling of fullness. The main adverse effects of GLP-1 agonists are gastrointestinal, including abdominal bloating, nausea, vomiting, and diarrhea. 

Recommendations

  • If HbA1c remains between 7% and 10% despite lifestyle modifications being carried out for 3-6 months, metformin is first-line pharmacotherapy.

  • If the HbA1c goal (<7%) is not achieved 3 to 6 months after the maximum dose of metformin therapy, addition of a second non-insulin treatment is required.

  • The expanded indication for liraglutide provides an additional non-insulin treatment option in the glycemic management of children with type 2 diabetes aged ≥10 years. 

The European Medicines Agency (EMA) has also recommended liraglutide be approved for the treatment of children and adolescents aged ≥10 years with type 2 diabetes. This drug is already approved by the EMA for use in adults with type 2 diabetes together with diet and exercise, either on its own or as an add-on to other diabetes medications.

See Management: approach

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • acanthosis nigricans
  • polyuria
  • polydipsia
  • nocturia

Other diagnostic factors

  • hypertension
  • yeast infections
  • skin infections
  • urinary tract infections
  • fatigue
  • blurred vision
  • weight loss

Risk factors

  • obesity
  • genetic predisposition/family history
  • African-American, Hispanic, American Indian, and Asian or Pacific Islander
  • puberty
  • female sex
  • small for gestation age
  • rapid growth in infancy
  • diabetic in-utero environment
  • bottle feeding
  • high protein intake in infancy
  • polycystic ovaries
  • intramyocellular lipid content
  • fat deposition in the liver

Diagnostic investigations

1st investigations to order

  • urine dipstick
  • random plasma glucose
  • fasting plasma glucose
  • HbA1c
  • autoantibodies to insulin, islet cell, glutamic acid decarboxylase, and zinc transporter 8
Full details

Investigations to consider

  • oral glucose tolerance test
  • C-peptide
Full details

Treatment algorithm

Contributors

Pediatric Endocrinology Fellow

Department of Pediatrics

University of Florida

Gainesville

FL

Disclosures

PH declares that he has no competing interests.

Jennifer Miller

Assistant Professor

Department of Pediatrics

University of Florida

Gainesville

FL

Disclosures

JM is an author of a reference cited in this topic.

Dr Paul Hiers and Dr Jennifer Miller wish to gratefully acknowledge Dr Arlan Rosenbloom, a previous contributor to this topic.

Peer reviewersVIEW ALL

Professor

Diabetes and Metabolic Endocrinology

School of Clinical Sciences

University of Bristol

UK

Disclosures

In the past, JPHS received speaking honoraria from Sanofi-Aventis, Roche, Abbott, Novo-Nordisk, and Nutricia. None of these talks were directly pertinent to the treatment of type 2 diabetes.

Professor of Pediatrics

University of California

Sacramento

CA

Disclosures

KN declares that she has no competing interests.

Professor of Pediatrics

Rumsey Chair of Pediatric Endocrinology

University of California

Sacramento

CA

Disclosures

DS declares that he has no competing interests.

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