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
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