MK-8835/PF-04971729 and Sitagliptin Co-administration Factorial Study

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) with Sitagliptin Compared with Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of subjects with T2DM With Inadequate Glycemic Control on Metformin Monotherapy

• IRAS ID

  153301

• Contact name

  Martin GIBSON

• Sponsor organisation

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

• Eudract number

  2013-003698-82

• Research summary

  The purpose of this study is to evaluate the effects of a research study drug called ertugliflozin on blood sugar (glucose) levels in people who have Type 2 diabetes and who have inadequate glyaemic control on metformin monotherapy. Ertugliflozin is being studied to see if it reduces the amount of glucose in the blood in diabetic patients who do not have adequate blood sugar control on their current diabetes treatment regimen.

  About 1250 people with T2 diabetes will participate in this study. Participants will be asked to visit their study doctor 10 times over a period of up to 69 weeks.

  Participants will be assigned to one of the following treatment arms:

  - 5 mg ertugliflozin and 100 mg sitagliptin (includes 10 mg matching placebo tablet for ertugliflozin)
  - 15 mg ertugliflozin and 100 mg sitagliptin
  - 5 mg ertugliflozin (includes 100 mg matching placebo tablet for sitagliptin and 10 mg matching placebo tablet for ertugliflozin)
  - 15 mg ertugliflozin (includes 100 mg matching placebo tablet for sitagliptin)
  - 100 mg sitagliptin

  Participants have an equal chance of being assigned to any of the above treatment arms.

  A number of assessments will be performed during the study including physical examinations, measurements of body weight, blood pressure and pulse rate, blood tests, urine tests and electrocardiograms (ECG). An ECG is a standard test that doctors use to monitor electrical activity of the heart. These assessments are performed as part of the evaluation to determine if ertugliflozin is effective and safe. 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.

  The study will be run at approximately 5 centres in the UK and is sponsored by Merck Sharp & Dohme Corp.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/1021

• Date of REC Opinion

  29 Sep 2014

• REC opinion

  Further Information Favourable Opinion