Patients with T2DM Inadequately Controlled with Diet and Exercise
Research type
Research Study
Full title
A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise
IRAS ID
236664
Contact name
Madhu Gowda
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2016-001857-42
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 10 months, 13 days
Research summary
The standard treatment for diabetes is currently diet and exercise with addition of oral and/or injectable medications, to reduce participants blood sugar levels. Keeping blood sugar levels under control is important as high sugar levels have been shown to significantly increase the risk of health problems (complications) developing later in life. Serious long-term complications include major adverse cardiovascular events (MACE; CV death, stroke) and other specific CV events (heart failure). Sanofi are developing an investigational drug called Efpeglenatide which has been tested previously in approximately 720 people and the results have shown a positive effect on glucose in the blood. Sanofi anticipate that all three once weekly doses (2mg, 4mg, and 6mg) used in this trial, in addition to diet and exercise will be more superior to diet and exercise alone in reducing participants blood sugar levels.
This current study is a multicentre study of Efpeglenatide given once weekly as subcutaneous injections (under the skin) in participants with Type 2 Diabetes Mellitus (T2DM). The study is funded by Sanofi. Approximately 400 participants will be recruited globally with around 34 participants recruited in the UK. Treatment will last for up to 56 weeks and maximum study duration for individual participants is expected to be 65 weeks.
The study is designed to demonstrate the efficacy and safety of efpeglenatide when used as monotherapy (a medical treatment using a single drug or therapy) in participants with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet and exercise. Efpeglenatide will be compared to placebo, consistent with regulatory guidance.
Eligible participants will be randomly assigned (like flipping a coin) to receive 1 of 3 dose levels of efpeglenatide (2, 4, or 6 mg) or to placebo (pill with no medicine), to be administered SC once-weekly. Participants will make a total of 15 visits (11 to the study centre and 4 by phone) over the next 15 months and receive an injection of efpeglenatide or matching placebo.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0149
Date of REC Opinion
9 May 2018
REC opinion
Further Information Favourable Opinion