A 34-week Follow-up to: MK-0431A in Pediatric Patients with Type 2 Diabetes Mellitus

• Research type

  Research Study

• Full title

  A 34-week Follow-up to: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients with Type 2 Diabetes Mellitus.

• IRAS ID

  169409

• Contact name

  Ravi Shankar

• Contact email

  ravi_shankar3@merck.com

• Sponsor organisation

  Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.

• Eudract number

  2014-003583-20

• Clinicaltrials.gov Identifier

  NCT01472367

• Duration of Study in the UK

  2 years, 10 months, 2 days

• Research summary

  This is 34 week multinational, placebo-controlled, double-blind extension/follow-up study to the base MK-0431A-170 study. This follow up study will continue to test the safety and tolerability of the addition of sitagliptin (given as MK-0431A/Janumet) in children 10-17 years old with Type 2 diabetes, whose blood sugar is not properly controlled with metformin treatment alone. This follow-up study starts at Extension Visit 1/Week 20 (which can occur concurrently with the last base study visit, or up to 14 days after the last dose of study medication has been taken on completion of the base study) and will continue for an additional 34 weeks until Extension Visit 4/Week 54.
  About 90 children and adolescents worldwide will be enrolled in the base MK-0431A-170 study. All patients randomized in the base study who reach the week 20 visit on study medication may be eligible to enter the extension study.

  There are 34 weeks of treatment followed by a telephone call that will be made two weeks after the last scheduled study visit. Patients will continue in the extension study on the same treatment that they received during the base study and will initiate insulin glargine as rescue therapy if their glycemic values meet protocol-specified thresholds.
  Subjects will attend 4 visits over the 34 week treatment period (with telephone calls in between the study visits). Patients will be monitored for their type 2 diabetes and general health and will be asked to provide blood samples throughout this follow-up study.
  There will be up to 10 subjects participating in this extension study in the UK. The study is funded and sponsored by MSD and will take place in UK Hospitals.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  15/EM/0004

• Date of REC Opinion

  26 Jan 2015

• REC opinion

  Further Information Favourable Opinion