Insulin sparing effects of Sitagliptin compared to placebo

• Research type

  Research Study

• Full title

  A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin

• IRAS ID

  94858

• Contact name

  Sharon Gillings

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

• Eudract number

  2011-004622-96

• Clinicaltrials.gov Identifier

  NCT01462266

• Research summary

  This is a multi-national, double blind, placebo controlled trial using Sitagliptin in patients with type 2 diabetes mellitus who have inadequate control on insulin alone or in combination with metformin. The purpose of the study is to examine the insulin-sparing effect of Sitagliptin 100mg once daily compared to placebo. The subjects will attend 9 visits over 29 weeks. This includes a 1 week screening period, a 2 week insulin switch/sulphonylurea wash off period if applicable, a 2 week single blind placebo run-in period and then a 24 week double-blind treatment period.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  11/EE/0506

• Date of REC Opinion

  30 Jan 2012

• REC opinion

  Further Information Favourable Opinion