A Study of Sitagliptin/Metformin in Pediatric Patients with Type 2 Diabetes Mellitus not Controlled on Metformin

Update Il y a 4 ans
Reference: EUCTR2011-002529-23

Woman and Man

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Extract

Base and extension study Over 20 weeks (base) and over 54 weeks (extension)-assess safety and tolerability of the addition of sitagliptin (as MK-0431A) in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin therapy Base study Pooled population ( MK-0431A P170 base study and MK-0431A XR P289 Phase A) to assess in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin therapy 1 After 20 weeks effect of the addition of sitagliptin (as MK-0431A or MK-0431A XR) relative to placebo on A1C 2 Over 20 weeks safety and tolerability of the addition of sitagliptin (as MK-0431A or MK-0431A XR) Extension study Pooled population [MK-0431A P170(base+extension study) and MK- 0431A XR P289(Phase A+B)] Over 54 weeks to assess the safety and tolerability of the addition of sitagliptin (as MK-0431A or MK-0431A XR) in pediatric patients (10-17 y.) with T2DM with inadequate glycemic control on metformin therapy


Inclusion criteria

  • Type 2 diabetes mellitus