A Five-year, Observational, Non-interventional Follow-up to: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control (MK-0431-351)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional observational follow-up study of a randomized clinical trial

Study drug and medical condition

• Medicinal product name:
  SITAGLIPTIN
• Study drug International non-proprietary name (INN) or common name:
  SITAGLIPTIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BH01) sitagliptin

  sitagliptin
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Pediatric patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control
• Estimated number of subjects:
  81

Study design details

• Main study objective:
  The objective is to provide an up to 5-year observational assessment of safety of participants with T2DM who were treated for up to one year with sitagliptin or metformin as initial monotherapy in a previous study.
• Outcomes:
  Number (%) of participants and follow-up adjusted incidence rates by treatment group for any adverse event (AE), AE system organ classes (SOC). Descriptive statistics by treatment group from a previous study for body mass index (BMI), body weight, height, Tanner Stage, growth velocity, diastolic and systolic blood pressure, pulse rate.
• Data analysis plan:
  Safety endpoints for the follow-up study will be summarized by treatment group from a previous study, with no between-group comparisons.