title: Metformin monotherapy in youth with recent onset type 2 diabetes: experience from the prerandomization run-in phase of the TODAY study.
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.
  
  
  METHODS
  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 0.68 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.
  
  
  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).
authors.affiliation: Joslin Diabetes Center, Pediatrics, Boston, MA 02215, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Laffel
authors.forename: Nancy
authors.initials: N
authors.lastname: Chang
authors.forename: Margaret
authors.initials: M
authors.lastname: Grey
authors.forename: Dan
authors.initials: D
authors.lastname: Hale
authors.forename: Laurie
authors.initials: L
authors.lastname: Higgins
authors.forename: Kathryn
authors.initials: K
authors.lastname: Hirst
authors.forename: Roberto
authors.initials: R
authors.lastname: Izquierdo
authors.forename: Mary
authors.initials: M
authors.lastname: Larkin
authors.forename: Christina
authors.initials: C
authors.lastname: Macha
authors.forename: Trang
authors.initials: T
authors.lastname: Pham
authors.forename: Aimee
authors.initials: A
authors.lastname: Wauters
authors.forename: Ruth S
authors.initials: RS
authors.lastname: Weinstock
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002648:Child; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D010349:Patient Compliance; D011897:Random Allocation; D015430:Weight Gain; D015431:Weight Loss
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin