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. 2016 Sep 18;2016(9):CD006992. doi: 10.1002/14651858.CD006992.pub2

EUCTR2011‐004622‐96‐ES.

Trial name or title Study to test the safety, tolerability, and effectiveness of sitagliptin when compared to placebo in reducing the amount of insulin (with or without metformin) needed per day, to control blood sugar, over a 24‐week period
Methods A phase III, multicenter, randomised, double‐blind, placebo‐controlled clinical trial to study the safety and insulin‐sparing efficacy of the addition of sitagliptin in ‐ Study to test the safety, tolerability, and effectiveness of sitagliptin when compared to placebo
Participants Participants with type 2 diabetes mellitus who have inadequate glycaemic control on insulin alone or in combination with metformin
Interventions Sitagliptin compared with placebo on the change in insulin dose in IU per day in people with type 2 diabetes mellitus (T2DM) with inadequate glycaemic control on insulin with or without metformin, who titrate insulin glargine (treat‐to‐target)
Outcomes Daily insulin dose, HbA1c, fasting plasma glucose, body weight
Starting date 23 December 2011
Contact information  
Notes Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc