Metformin monotherapy in youth with recent onset type 2 diabetes: Experience from the prerandomization run-in phase of the TODAY study

Lori Laffel, Nancy Chang, Margaret Grey, Dan Hale, Laurie Higgins, Kathryn Hirst, Roberto Izquierdo, Mary Larkin, Christina Macha, Trang Pham, Aimee Wauters, Ruth S. Weinstock

Research output: Contribution to journalArticle

26 Scopus citations

Abstract

Background: TODAY (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. Objective: To 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). Methods: A 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. Results: At 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 0.68kg and HbA1c by 1.45% compared to a weight gain of 0.71kg 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. Conclusions: Most 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).

Original languageEnglish (US)
Pages (from-to)369-375
Number of pages7
JournalPediatric Diabetes
Volume13
Issue number5
DOIs
StatePublished - Aug 2012

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Keywords

  • Clinical trial
  • Hemoglobin A1c
  • Metformin
  • Pediatric onset
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Pediatrics, Perinatology, and Child Health
  • Endocrinology, Diabetes and Metabolism

Cite this

Laffel, L., Chang, N., Grey, M., Hale, D., Higgins, L., Hirst, K., Izquierdo, R., Larkin, M., Macha, C., Pham, T., Wauters, A., & Weinstock, R. S. (2012). Metformin monotherapy in youth with recent onset type 2 diabetes: Experience from the prerandomization run-in phase of the TODAY study. Pediatric Diabetes, 13(5), 369-375. https://doi.org/10.1111/j.1399-5448.2011.00846.x