A monotherapy study of ertugliflozin in participants with T2DM
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo Controlled, 26-Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise
IRAS ID
140052
Contact name
Melanie Davies
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2013-002519-90
Clinicaltrials.gov Identifier
Research summary
Type 2 diabetes mellitus (T2DM) is a disorder of metabolism that is characterised by high blood glucose, insulin resistance and relative insulin deficiency.
There has been an increase in the occurrence of T2DM all around the world. Nearly 90-95% of all people who have diabetes, have T2DM. People with T2DM have a higher risk of getting diseases of blood vessels which can cause complications in the kidneys, nerves, eyes and heart. Medicines that lower blood sugar as well as reduce other health risks e.g. by lowering body weight and reducing blood pressure could be helpful in the treatment of diabetes.
The study drug, ertugliflozin, acts on the kidneys causing sugar to get passed out of the body in the urine without coming back into blood. This lowers the sugar level in blood.
The purpose of this research study is to study the effects of ertugliflozin in the treatment of T2DM. Ertugliflozin will be compared with a placebo. A placebo looks like the study drug but does not contain any active substance. Ertugliflozin is an investigational drug. An investigational drug is one that is currently not approved for sale in this country.
Because this is a research study, ertugliflozin will be given to participants only during this study and not after the study is over. There will be about 450 people enrolled in this study. The study is being done at about 80 different research sites in approximately 8 countries.
This is a research study involving both Pfizer and Merck & Co. Pfizer is responsible for conducting this study. Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co, Inc.) is the regulatory sponsor of this study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0344
Date of REC Opinion
14 Feb 2014
REC opinion
Further Information Favourable Opinion