Trial reportDiabetes care2013
Safety and tolerability of the treatment of youth-onset type 2 diabetes: the TODAY experience.
Trial report in Diabetes care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00081328. Cited by 24 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial
Who cites it
24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- An Updated Systematic Review and Meta-Analysis on the Efficacy and Safety of Metformin as Add-on Therapy to Insulin in Patients With Type 1 Diabetes.Endocrinology, diabetes & metabolism · 2025Pooled it
- 2023 Clinical Practice Guidelines for Diabetes Management in Korea: Full Version Recommendation of the Korean Diabetes Association.Diabetes & metabolism journal · 2024Guideline
- Comparative efficacy and safety of glucose-lowering drugs in children and adolescents with type 2 diabetes: A systematic review and network meta-analysis.Frontiers in endocrinology · 2022Pooled it
- Effect and Safety of Adding Metformin to Insulin Therapy in Treating Adolescents With Type 1 Diabetes Mellitus: An Updated Meta-Analysis of 10 Randomized Controlled Trials.Frontiers in endocrinology · 2022Pooled it
- Metformin for Weight Gain Associated with Second-Generation Antipsychotics in Children and Adolescents: A Systematic Review and Meta-Analysis.CNS drugs · 2018Pooled it
- Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study.The lancet. Diabetes & endocrinology · 2022Trial
- 14. Children and Adolescents: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- 2025 Clinical Practice Guidelines for Diabetes Management in Korea: Recommendation of the Korean Diabetes Association.Diabetes & metabolism journal · 2025Article
- 14. Children and Adolescents: Standards of Care in Diabetes-2025.Diabetes care · 2025Review
- Improving Prescribing Rates of Glucagon-Like Peptide 1 Receptor Agonists in Youth With Type 2 Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2025Article
- Article
- Type 2 diabetes in children and adolescents: Exploring the disease heterogeneity and research gaps to optimum management.World journal of clinical pediatrics · 2024Review
- Are treatment options used for adult-onset type 2 diabetes mellitus (equally) available and effective for children and adolescents?World journal of diabetes · 2024Review
- A practical evidence-based approach to management of type 2 diabetes in children and young people (CYP): UK consensus.BMC medicine · 2024Article
- 14. Children and Adolescents: Standards of Care in Diabetes-2024.Diabetes care · 2024Review
- A1C: Episode 2.Clinical diabetes : a publication of the American Diabetes Association · 2024Review
- 14. Children and Adolescents: Standards of Care in Diabetes-2023.Diabetes care · 2023Review
- Diagnosis, treatment and prevention of type 2 diabetes mellitus in children and adolescents.World journal of diabetes · 2021Review
- Metformin treatment and gastrointestinal symptoms in youth: Findings from a large tertiary care referral center.Pediatric diabetes · 2021Article
- Type 2 Diabetes Mellitus in Adolescents From Southern India - A Single Center Experience.Indian pediatrics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
Abstract
objectiveData related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO). RESEARCH DESIGN AND
methodsObese 10- to 17-year-olds (N = 699) with type 2 diabetes for <2 years and hemoglobin A1c (A1C) ≤ 8% on metformin monotherapy were randomized to one of three treatments: metformin, metformin plus rosiglitazone (M + R), or metformin plus lifestyle program (M + L). Participants were followed for 2-6.5 years.
resultsGastrointestinal (GI) disturbance was the most common AE (41%) and was lower in the M + R group (P = 0.018). Other common AEs included anemia (20% before PO, 14% after PO), abnormal liver transaminases (16, 15%), excessive weight gain (7, 9%), and psychological events (10, 18%); the AEs were similar across treatments. Permanent medication reductions/discontinuations occurred most often because of abnormal liver transaminases and were lowest in the M + R group (P = 0.005). Treatment-emergent SAEs were uncommon and similar across treatments. Most (98%) were unrelated or unlikely related to the study intervention. There were no deaths and only 18 targeted SAEs (diabetic ketoacidosis, n = 12; severe hypoglycemia, n = 5; lactic acidosis, n = 1). There were 62 pregnancies occurring in 45 participants, and 6 infants had congenital anomalies.
conclusionsThe TODAY study represents extensive experience managing type 2 diabetes in youth and found that the three treatment approaches were generally safe and well tolerated. Adding rosiglitazone to metformin may reduce GI side effects and hepatotoxicity.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.