MK-0431A in Pediatric Patients with Type 2 Diabetes Mellitus

• Research type

  Research Study

• Full title

  A Phase III, Multicenter, Double-Blind, Randomized, Placebo -Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients with Type 2 Diabetes Mellitus)

• IRAS ID

  87747

• Contact name

  Timothy Barrett

• Sponsor organisation

  Merck Sharp & Dohme Ltd

• Eudract number

  2011-002529-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a multinational, double-blind paediatric study using the study drug Sitagliptin combined with Metformin (Janumet), in patients with inadequate glycemic control on metformin monotherapy. In this study the use of Sitagliptin combined with Metformin to treat children ages 10-17 years old with Type 2 Diabetes will be investigated. The purpose of the study is to see if Sitagliptin combined with Metformin therapy in a fixed dose combination tablet, can help control diabetes when compared to placebo added to ongoing Metformin therapy. Subjects will attend 9 visits over 22 weeks. This includes a screening visit, a 1 week placebo run-in and switch to sponsor supplied metformin period and a 20 week treatment period followed by a telephone contact 14 days after the last dose of study medication.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0398

• Date of REC Opinion

  13 Dec 2011

• REC opinion

  Further Information Favourable Opinion