US FDA approves liraglutide for use in children ≥10 years with type 2 diabetes
The US Food and Drug Administration has expanded the use of liraglutide to include the treatment of children aged ≥10 years with type 2 diabetes.[75]
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 glycaemic control in around half of paediatric patients and that combination treatment or insulin therapy is required in most.[73]
The efficacy and safety of liraglutide for reducing blood sugar in paediatric 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 haemoglobin 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.[76]
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 minimises the risk of hypoglycaemia. 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 diarrhoea.
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 3-6 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 glycaemic 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 or older 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.
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Summary
Definition
History and exam
Key diagnostic factors
- presence of risk 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
- high-risk ethnic background
- puberty
- female sex
- small for gestation age
- rapid growth in infancy
- diabetic in-utero environment
- bottle feeding
- high protein intake in infancy
- polycystic ovaries
- intra-myocellular lipid content
- fat deposition in the liver
Diagnostic investigations
Treatment algorithm
Contributors
Authors
Pediatric Endocrinology Fellow
Department of Pediatrics
University of Florida
Gainesville
FL
Disclosures
PH declares that he has no competing interests.
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 reviewers
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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