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
Definition
History and exam
Key diagnostic factors
- polyuria
- polydipsia
- acanthosis nigricans
- 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
- 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
Diagnostic tests
1st tests to order
- 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)
Tests to consider
- 2-hour plasma glucose
- random C-peptide
Treatment algorithm
ketoacidosis or hyperglycemic hyperosmolar state (HHS)
HbA1c <8.5%: no acidosis or ketosis
HbA1c ≥8.5%: no acidosis with or without ketosis
Contributors
Authors
Jennifer Miller, MD

Professor
Department of Pediatrics
University of Florida
Gainesville
FL
Disclosures
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
Disclosures
CZ declares that she has no competing interests.
Acknowledgements
Dr Jennifer Miller and Dr Chelsea Zimmerman would like to gratefully acknowledge Dr Arlan Rosenbloom and Dr Paul Hiers, previous contributors to this topic.
Disclosures
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.
Peer reviewers
Philip Zeitler, MD, PhD
Professor of Pediatrics and Clinical Science
University of Colorado School of Medicine
Aurora
CO
Disclosures
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
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.
Kristen Nadeau, MD
Professor of Pediatric Endocrinology
University of Colorado School of Medicine
Aurora
CO
Disclosures
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.
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 treatments work?
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