Ertugliflozin in subjects w/ T2DM & poor glycemic control on metformin
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,26-WEEK MULTICENTER STUDY WITH A 78-WEEK EXTENSION TO EVALUATE THE EFFICACY AND SAFETY OF ERTUGLIFLOZIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND INADEQUATE GLYCEMIC CONTROL ON METFORMIN MONOTHERAPY
IRAS ID
145608
Contact name
Thomas Barber
Contact email
Sponsor organisation
Pfizer, Inc.
Eudract number
2013-003290-95
Clinicaltrials.gov Identifier
Research summary
Type 2 diabetes mellitus (T2DM) is a disorder of metabolism that is characterised by insulin resistance, high blood glucose levels resulting into insulin–deficiency over time.
There is an increase in the prevalence and incidence of T2DM all around the world. Nearly 90-95% of all people who have diabetes, have T2DM. Compared to normal participants, people with T2DM have a higher risk of getting diseases of blood vessels which can cause complications in the kidneys, nerves, eyes and heart and brain. Medicines that lower blood sugar as well as reduce other health risks e.g. 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 by increasing urinary glucose excretion.
The purpose of this research study is to study the effects of ertugliflozin on blood glucose control in the treatment of T2DM in participants who have poor sugar control (glycaemic control) and are being treated with metformin.
The study will also assess the effects of ertugliflozin after 104 weeks of treatment on the safety and tolerability of the participants. It has also the additional purpose to find out how safe ertugliflozin is for bone health, especially in women who have had their menopause. Ertugliflozin will be compared with a placebo.
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 600 people enrolled in this study. The study is being done at about 111 different research sites in approximately 15 countries.
This 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
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0202
Date of REC Opinion
12 Jun 2014
REC opinion
Further Information Favourable Opinion