Exenatide Study of Cardiovascular Event Lowering (EXSCEL)
Research type
Research Study
Full title
A RANDOMISED PLACEBO CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
IRAS ID
58738
Contact name
Naveed Sattar
Sponsor organisation
Eli Lilly and Company
Eudract number
2010-021069-63
Clinicaltrials.gov Identifier
Research summary
Type 2 Diabetes Mellitus (T2DM) is a leading health problem. The number of People'suffering from diabetes might reach 300 million by 2025. Cardiovascular Disease (CVD) is the leading cause of death in T2DM patients. Patients with T2DM have high levels of blood glucose (sugar) as a result of the inability to properly produce and/or use insulin which is needed to take sugar from the blood to the cells. The high level of sugar in the blood causes damage to the kidneys, nerves, and blood vessels and can lead to CVD. Lowering LDL cholesterol, blood pressure and blood glucose levels can reduce the risk of CVD in T2DM patients. The EXSCEL (Exenatide Study of Cardiovascular Event Lowering) study is a long-term, placebo-controlled (an injection that looks the same as the study drug but has no medicine in it), double-blinded trial (neither the patient nor the study doctor will know what medicine patients are taking) which will examine the effects of a once weekly injection of Exenatide on CVD in patients with T2DM. Exenatide is currently available under the trade name BYETTA as a twice daily injection. Exenatide once weekly (EQW) is a new formulation that is injected once weekly in addition to the standard treatment for T2DM. Previous studies of EQW showed reductions in blood sugar, LDL cholesterol, blood pressure and body weight thus presenting a new T2DM treatment that reduces blood sugar and could have a positive effect on major CVD risk factors in patients with T2DM. Patients participating in this study will be randomly assigned to one of two groups: 1) EQW standard treatment 2) Placebo standard treatment The EXSCEL study will be conducted in approximately 500 sites worldwide with approximately 9500 patients. Patients will be followed for at least 4 years. The EXSCEL study will be sponsored by Eli Lilly and Company within the U.K.
REC name
Scotland A REC
REC reference
11/AL/0042
Date of REC Opinion
12 Apr 2011
REC opinion
Further Information Favourable Opinion