Ertugliflozin versus Placebo in Paediatric Type 2 Diabetes
Research type
Research Study
Full title
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Mellitus
IRAS ID
261870
Contact name
Evelien Gevers
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2017-003455-35
Duration of Study in the UK
6 years, 2 months, 19 days
Research summary
The frequency of type 2 diabetes mellitus (T2DM) in the paediatric population is increasing worldwide. T2DM is associated with vascular (blood vessel) issues and may lead to further clinical complications in adulthood. While lifestyle modification is an effective treatment, it is difficult to implement and maintain, and tends to benefit a relative minority of youths.
Metformin and insulin are the only agents approved to treat T2DM in paediatric patients. However, treatment can be difficult to administer as the metformin pill can be hard to swallow whilst insulin is administered as an injection which can be unfavourable. These factors can limit the use of these medicines and the development of a more acceptable alternative is essential.
Ertugliflozin is a sodium-glucose transport protein 2 (SGLT2) inhibitor being co-developed by Merck and Pfizer. SGLT2 are proteins, located in the kidneys, which are involved in maintaining glucose levels in the blood. An SGLT2 inhibitor can prevent the reabsorption of glucose in the kidneys, causing a decrease in blood glucose levels. Ertugliflozin is approved for the treatment of T2DM in adults and has been shown to reduce blood glucose levels in patients with T2DM treated with metformin ± insulin. Ertugliflozin has also been shown to improve body weight and blood pressure in adults with T2DM.
The purpose of this study is to evaluate the safety and efficacy of ertugliflozin in paediatric patients with T2DM. This phase III study will last approximately 6 years and will recruit approximately 150 participants, aged 10-17 years old, with T2DM on a stable dose of metformin ± stable insulin. Participants will be assigned randomly to one of two treatment groups receiving either ertugliflozin or a placebo (dummy drug).
The study is sponsored by Merck Sharp & Dohme Limited (MSD) and will take place at three study centres in the UK.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1043
Date of REC Opinion
26 Sep 2019
REC opinion
Further Information Favourable Opinion