MK-8835/PF-PF-04971729 and Sitagliptin Initial Combination Study
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) with Sitagliptin in the Treatment of Subjects with T2DM with Inadequate Glycemic Control on Diet and Exercise
IRAS ID
165755
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2014-001049-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
The purpose of this study is to evaluate the safety and efficacy of the combination of ertugliflozin (a research study drug) with sitagliptin compared to placebo in adults with Type 2 diabetes without adequate blood sugar control while on diet and exercise. Ertugliflozin is being studied as add-on therapy to diet and exercise and in combination with other anti-diabetes medicines to see if it reduces the amount of sugar in the blood in patients with Type 2 diabetes. Sitagliptin has been approved by the MHRA
About 300 people will participate in this study globally. Participants will be asked to visit their study doctor 8 times over a period of 39 weeks. Most visits will last about 1.5 hours.
Participants will be assigned to one of the following treatment groups:
• ertugliflozin 5 mg and sitagliptin 100 mg
• ertugliflozin 15 mg and sitagliptin 100 mg
• placebos for ertugliflozin and sitagliptin. A placebo is a look-alike tablet with no active ingredients.Participants have an equal chance of being assigned to any of the treatment groups. During the study, neither you nor the study doctor will know to which group you have been assigned.
A number of assessments will be performed during the study including physical examinations, measurement of weight, blood pressure and heart rate, blood tests, urine tests and electrocardiograms (ECG). These assessments are performed as part of the evaluation to determine if the study drug is working and/or to monitor participants’ health. Participants will be given instructions about recommended diet and exercise plans, instructed to measure their blood sugar levels at home with a glucose meter at least twice a week and use a log book to record low blood sugar levels.
The study will be conducted at 11 centres in the UK and is sponsored by Merck Sharp & Dohme Corp.
REC name
London - Central Research Ethics Committee
REC reference
14/LO/1876
Date of REC Opinion
6 Jan 2015
REC opinion
Further Information Favourable Opinion