Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)
Condition: Diabetes Mellitus; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety of the addition of sitagliptin, and its
      effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2
      diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this
      study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment.
    

Detailed description: 
      This trial is of approximately 56 weeks in duration, including a screening period of up to 1
      week, a 1-week single-blind placebo run-in period, a 20-week placebo-controlled, double blind
      treatment period [Phase A] and a 34-week double-blind active controlled treatment period
      [Phase B] during which participants randomized to the placebo arm who have not initiated
      glycemic rescue therapy with metformin during Phase A will receive metformin (in a blinded
      manner). A telephone contact will be performed 14 days after the last dose of study
      medication to assess for any serious adverse events (SAEs).

      Participants enrolled in the metformin and placebo/sitagliptin arms prior to implementation
      of Protocol Amendment 05 completed the study on their original treatment assignments.

      EUPASS4468 is a follow-up, non-interventional, observational assessment of safety of
      participants who participated in the MK-0431-083 study for up to 5 years.
    

Intervention name(s): Sitagliptin; Metformin; Placebo to sitagliptin; Placebo to metformin; Glycemic Rescue 1; Glycemic Rescue 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Biological
Intervention description(s): Sitagliptin 100 mg tablet administered orally once daily; Metformin 500 mg tablets administered orally starting at 500 mg/day and uptitrated by 500 mg every week to a final dose of 1000 mg twice daily; Matching placebo to sitagliptin 100 mg tablet administered orally once daily; Matching placebo to metformin 500 mg tablets, 2 tablets administered orally twice daily; Participants in the sitagliptin arm who require glycemic rescue will receive metformin during Weeks 0-20 and Weeks 20-54. Participants in the placebo arm who require glycemic rescue will receive metformin during Weeks 0-20. Participants in the placebo arm who have switched to metformin during Weeks 20-54 and require glycemic rescue will receive sitagliptin.; Participants who require glycemic rescue after Glycemic Rescue 1 will receive open-label insulin. Participants on background insulin therapy will have the dose of their background insulin up-titrated.
Other intervention name(s): Januvia®, Tesavel®, Xelevia®, Ristaben®, Glactiv®; Glucophage®, Metgluco®, Glycoran®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment