Dapagliflozin approved by FDA for treatment of type 2 diabetes in children
The sodium-glucose cotransporter-2 (SGLT2) inhibitor dapagliflozin has been approved by the Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type 2 diabetes ages 10 years and older. Prior to this, dapagliflozin was approved only in adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control.
The approval in pediatric patients was based on results from T2NOW, one of the largest pediatric type 2 diabetes phase 3 trials to date. Data demonstrated a significant reduction in hemoglobin A1c (HbA1c) for patients treated with dapagliflozin compared with patients receiving placebo.The safety results in this patient population were consistent with those in adults with type 2 diabetes.
Dapagliflozin has also received approval from the European Medicines Agency (EMA) for use in children ages ≥10 years with uncontrolled type 2 diabetes as an adjunct to diet and exercise.
Summary
Определение
Анамнез и осмотр
Ключевые диагностические факторы
- polyuria
- polydipsia
- acanthosis nigricans
- nocturia
Другие диагностические факторы
- hypertension
- yeast infections
- skin infections
- urinary tract infections
- fatigue
- blurred vision
- weight loss
Факторы риска
- obesity
- genetic predisposition/family history
- African-American, Hispanic, American-Indian, and Asian or Pacific Islander
- puberty
- female sex
- diabetic in-utero environment
- small for gestational age
- rapid growth in infancy
- bottle feeding
- high protein intake in infancy
- polycystic ovaries
- intramyocellular lipid content
- fat deposition in the liver
- learning disability
Диагностические исследования
Исследования, которые показаны в первую очередь
- urine dipstick
- random plasma glucose
- fasting plasma glucose
- HbA1c
- autoantibodies to insulin, islet antigen (IA-2), glutamic acid decarboxylase (GAD), and zinc transporter 8 (ZnT8)
Исследования, проведение которых нужно рассмотреть
- 2-hour plasma glucose
- random C-peptide
Алгоритм лечения
ketoacidosis or hyperglycemic hyperosmolar state (HHS)
HbA1c <8.5%: no acidosis or ketosis
HbA1c ≥8.5%: no acidosis with or without ketosis
Составители
Авторы
Jennifer Miller, MD

Professor
Department of Pediatrics
University of Florida
Gainesville
FL
Раскрытие информации
JM declares that she has received research funding from Soleno Therapeutics, Harmony Biosciences, and Rhythm Pharmaceuticals. JM is an author of a reference cited in this topic.
Chelsea Zimmerman, MD
Clinical Physician
Pediatric Endocrinology
Endocrinology and Metabolism of East Alabama
Opelika
AL
Раскрытие информации
CZ declares that she has no competing interests.
Выражение благодарностей
Dr Jennifer Miller and Dr Chelsea Zimmerman would like to gratefully acknowledge Dr Arlan Rosenbloom and Dr Paul Hiers, previous contributors to this topic.
Раскрытие информации
AR is an author of a number of references cited in this topic. Unfortunately, we have since been made aware that AR is deceased. PH declares that he has no competing interests.
Рецензенты
Philip Zeitler, MD, PhD
Professor of Pediatrics and Clinical Science
University of Colorado School of Medicine
Aurora
CO
Раскрытие информации
PZ declares that he has no competing interests.
Julian P. Hamilton-Shield, MB, ChB, MD(Bristol), MRCP, FRCPCH, FRCPCH
Professor
Diabetes and Metabolic Endocrinology
School of Clinical Sciences
University of Bristol
UK
Раскрытие информации
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.
Kristen Nadeau, MD
Professor of Pediatric Endocrinology
University of Colorado School of Medicine
Aurora
CO
Раскрытие информации
KN declares that she has no competing interests.
Dennis Styne, MD
Professor of Pediatrics
Rumsey Chair of Pediatric Endocrinology
University of California
Sacramento
CA
Disclosures
DS declares that he has no competing interests.
Peer reviewer acknowledgements
BMJ Best Practice topics are updated on a rolling basis in line with developments in evidence and guidance. The peer reviewers listed here have reviewed the content at least once during the history of the topic.
Disclosures
Peer reviewer affiliations and disclosures pertain to the time of the review.
References
Key articles
American Diabetes Association. Standards of care in diabetes - 2025. Diabetes care. 2025 Jan;48(suppl 1):S1-352.Full text
Shah AS, Barrientos-Pérez M, Chang N, et al. ISPAD clinical practice consensus guidelines 2024: type 2 diabetes in children and adolescents. Horm Res Paediatr. 2024;97(6):555-83.Full text Abstract
Glaser N, Fritsch M, Priyambada L, et al. ISPAD clinical practice consensus guidelines 2022: diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes. 2022 Nov;23(7):835-56. Abstract
Reference articles
A full list of sources referenced in this topic is available to users with access to all of BMJ Best Practice.
Differentials
- Impaired glucose tolerance
- Type 1 diabetes mellitus (T1DM)
- Monogenic diabetes: maturity-onset diabetes of the young
More DifferentialsGuidelines
- Standards of care in diabetes - 2025
- Type 2 diabetes in children and adolescents
More GuidelinesPatient information
Diabetes type 2: should I take insulin?
Diabetes type 2: what are the treatment options?
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