A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes.

OBJECTIVE: To evaluate the single-dose pharmacokinetics (PK), pharmacodynamics (PD), and safety of sitagliptin in pediatric patients with type 2 diabetes mellitus (T2DM). STUDY DESIGN: This was a randomized, placebo-controlled, double-blind evaluation of sitagliptin in 35 patients 10 to 17 years old with T2DM at 7 clinical research sites. The safety, tolerability, PK, and PD (dipeptidyl peptidase-4 [DPP-4] inhibition and aspects of glucose metabolism) of single doses of 50, 100, and 200 mg were assessed. Appropriate transformations on the PK parameters were used and back-transformed summary statistics are reported. RESULTS: Adverse experiences were reported by eight study participants; all were of mild intensity except one (intravenous site pain of moderate intensity). PK characteristics in the young patients were comparable to reference adult data, with geometric mean ratios (youths/adults) for AUC0-∞ , Cmax , and C24hr of 0.82, 1.04, and 0.74, respectively. Single doses of 50, 100, and 200 mg sitagliptin inhibited 67.2%, 73.8%, and 81.2% of plasma DPP-4 activity over 24 hours, respectively. Least squares (LS) mean glucose concentrations 2 hours after an oral glucose tolerance test or a meal tolerance test decreased in study participants treated with sitagliptin, compared to placebo, while active LS mean glucagon-like peptide 1 concentrations increased significantly at all sitagliptin doses in both tests. CONCLUSIONS: Single doses of sitagliptin as high as 200 mg were generally well tolerated in 10- to 17-year-old male and female study participants with T2DM, and a daily sitagliptin dose of 100 mg is appropriate for evaluation in Phase III safety and efficacy studies in pediatric patients with T2DM. (ClinicalTrials.gov: NCT00730275).

Outcome Analysis of The B.E. S.T.R.O.N.G. Childhood Obesity Treatment Program: Effectiveness of an Eight-Week Family-Based Childhood Obesity Program Using an Internet-Based Health Tracker.

BACKGROUND: We describe the development, testing, and analysis of the B.E. S.T.R.O.N.G. program, a comprehensive family-based multidisciplinary child obesity treatment program. The program uses an innovative Internet-based health tracker that was developed by the Children's Wellness Institute (CWI) for data collection, analysis, and storage. METHODS: Data were obtained on 112 subjects who enrolled in the B.E. S.T.R.O.N.G. program in several healthcare institutions during the 2013-2014 academic year. There were 74 females and 38 males. The mean age was 9.75 ± 2.21 years. There were 89 white, 14 African American, 3 Hispanic, and 6 listed as other. Height and weight data were collected during the first, fourth, and seventh week. Diet and exercise data were collected in a HIPAA-compliant manner each week for seven weeks, using the health tracker, and transmitted electronically for statistical analysis and storage. RESULTS: Subjects involved in the program demonstrated significant weight loss, averaging 3.8% reduction in BMI from their starting point. Weight loss in these subjects was associated with significant and measurable changes in diet, physical activity, and screen time. Participants in the B.E. S.T.R.O.N.G. program increased fruit and vegetable consumption to more than five daily servings and also demonstrated significant increases in the consumption of grains and protein foods. Furthermore, they maintained screen time at less than one hour per day, and increased all forms of physical activity to exceed one hour daily. CONCLUSIONS: The Internet-based health tracker demonstrated the effectiveness of the B.E. S.T.R.O.N.G. program, delivered by several healthcare institutions, in treating childhood obesity.