Trial reportPediatric diabetes2012
Metformin monotherapy in youth with recent onset type 2 diabetes: experience from the prerandomization run-in phase of the TODAY study.
Trial report in Pediatric diabetes, 2012. 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 30 papers, 2 of them syntheses that pooled it.
What it found
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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
30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- ISPAD Clinical Practice Consensus Guidelines 2024: Type 2 Diabetes in Children and Adolescents.Hormone research in paediatrics · 2024Guideline
- Drug interventions for the treatment of obesity in children and adolescents.The Cochrane database of systematic reviews · 2016Pooled it
- Insulin clearance at randomisation and in response to treatment in youth with type 2 diabetes: a secondary analysis of the TODAY randomised clinical trial.Diabetologia · 2025Trial
- Postintervention Effects of Varying Treatment Arms on Glycemic Failure and β-Cell Function in the TODAY Trial.Diabetes care · 2021Trial
- Self-Monitoring of Blood Glucose in Youth-Onset Type 2 Diabetes: Results From the TODAY Study.Diabetes care · 2019 · on this mapTrial
- Presentation and effectiveness of early treatment of type 2 diabetes in youth: lessons from the TODAY study.Pediatric diabetes · 2016 · on this mapTrial
- HbA1c After a Short Period of Monotherapy With Metformin Identifies Durable Glycemic Control Among Adolescents With Type 2 Diabetes.Diabetes care · 2015 · on this mapTrial
- Treatment effects on measures of body composition in the TODAY clinical trial.Diabetes care · 2013 · on this mapTrial
- Effects of metformin, metformin plus rosiglitazone, and metformin plus lifestyle on insulin sensitivity and β-cell function in TODAY.Diabetes care · 2013 · on this mapTrial
- Article
- Current Perspectives for Treating Adolescents with Obesity and Type 2 Diabetes: A Review.Nutrients · 2024Review
- Converging Pathways between Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Diabetes in Children.International journal of molecular sciences · 2024Review
- Article
- A practical evidence-based approach to management of type 2 diabetes in children and young people (CYP): UK consensus.BMC medicine · 2024Article
- Effect of Early Glycemic Control in Youth-Onset Type 2 Diabetes on Longer-Term Glycemic Control and β-Cell Function: Results From the TODAY Study.Diabetes care · 2023Article
- Glucagon-like Peptide-1 Receptor Agonists for the Treatment of Type 2 Diabetes in Youth.TouchREVIEWS in endocrinology · 2023Review
- Initial Insights into the Genetic Variation Associated with Metformin Treatment Failure in Youth with Type 2 Diabetes.Pediatric diabetes · 2023Article
- Treatment strategy for children and adolescents with type 2 diabetes-based on ISPAD Clinical Practice Consensus Guidelines 2022.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2023Review
- Medication-induced weight gain and advanced therapies for the child with overweight and obesity: An Obesity Medicine Association (OMA) Clinical Practice Statement 2022.Obesity pillars · 2022Article
- Deterioration of Glycemic Control in Youth-Onset Type 2 Diabetes: What Are the Early and Late Predictors?The Journal of clinical endocrinology and metabolism · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundTODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) is a federally funded multicenter randomized clinical trial comparing three treatments of youth onset type 2 diabetes.
objectiveTo describe the experience of youth participating in a 2-6 month run-in period in preparation for randomization into TODAY. SUBJECTS: An ethnically diverse sample of 927 youth, 65.4% females, aged 13.7 ± 2.0 yr old, with type 2 diabetes for a median of 2 months (0.7-7.8 months, 25th-75th percentiles).
methodsA run-in period was conducted to achieve HbA1c <8% with metformin monotherapy and diabetes education, and to evaluate adherence to pill taking, visit attendance, and other procedures.
resultsAt entry, mean body mass index (BMI) and z-BMI were 35.6 ± 7.7 and 2.3 ± 0.4, respectively, mean HbA1c was 7.7 ± 2.2%, only 42.5% were on a hypoglycemic treatment, and 35.6% had HbA1c ≥8%. Comorbid conditions were common; 18.8% had hypertension, 24.2% had elevated cholesterol, and 6.5% had abnormal liver enzymes. After a median 71 d of run-in, 90.9% had HbA1c <8%, 77.9% had HbA1c <7%, and 46.4% had HbA1c <6%. Of the 772 youth achieving the target HbA1c <8%, 704 (91.2%) were randomized; non-adherence to metformin treatment was the main cause for non-randomization. Youth proceeding to randomization decreased weight by 0.68 kg and HbA1c by 1.45% compared to a weight gain of 0.71 kg and HbA1c decrease of 0.74% in the non-randomized youth (p = 0.01 in both cases). However, change in z-BMI was not significantly different between the two groups.
conclusionsMost youth with recent onset type 2 diabetes can achieve target HbA1c <8.0% with short-term metformin monotherapy and standard diabetes education (ClinicalTrials.gov identifier: NCT00081328).
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What OpenQuestion 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 OpenQuestion graph.