Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) V(a)
Research type
Research Study
Full title
The Effect of Dulaglutide on Major Cardiovascular Events in Patients with Type 2 Diabetes: REsearching Cardiovascular Events with a Weekly INcretin in Diabetes (REWIND)
IRAS ID
86159
Contact name
Helen Colhoun
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2010-023799-21
Research summary
Type 2 diabetes remains an important risk factor for serious cardiovascular disease, and treatments that can reduce this risk by reducing blood sugar levels are urgently needed. Dulaglutide (LY2189256) is a modified form of the gut hormone glucagon-like peptide 1 (GLP1). Since GLP1 enhances insulin release, dulaglutide is expected to cause insulin release and lower blood sugar in people with type 2 diabetes.The aim of this international trial is to see if adding a once-weekly subcutaneous injection with 1.5 mg dulaglutide to existing diabetes treatment reduces the incidence of major cardiovascular problems and other serious complications when compared to treatment with placebo (identical-looking inactive drug). The safety and tolerability of dulaglutide will also be studied. Approximately 9600 patients aged 50 or older with type 2 diabetes and cardiovascular disease or cardiovascular risk factors will be allocated randomly (like flipping a coin) to receive either dulaglutide or placebo. Patients will be assessed 2 weeks, 3 months, and 6 months after study treatment allocation and then at 6-monthly intervals until they experience one of the pre-specified major endpoint events. The study assessments will include: - physical examinations - measurement of blood pressure, heart rate, weight, and waist and hip circumference. - ECGs (heart traces) - blood and urine sample collection to measure kidney function, blood lipids and calcitonin (a thyroid hormone) - tests to assess mental function - completion by male patients of erectile function questionnaires The study will end when 1067 patients experience one of the endpoint events. It is expected that individual patients will be in the study for between 5 and 8 years. The duration of this trial will also allow the long term effects of dulaglutide on thyroid calcitonin-producing (c-cell) activity, microvascular (small blood vessel) problems and the incidence of pancreatitis to be studied.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
11/ES/0029
Date of REC Opinion
13 Feb 2012
REC opinion
Further Information Favourable Opinion