Alirocumab/Placebo in Insulin Treated Diabetics with High Cholesterol
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients with Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy.
IRAS ID
189187
Contact name
Timothy Reynolds
Contact email
Sponsor organisation
Sanofi-Aventis Group
Eudract number
2015-000799-92
Duration of Study in the UK
1 years, 1 months, 9 days
Research summary
This study is to determine whether alirocumab, given by injection under the skin every 2 weeks for 6 months, is safe and effective in lowering blood cholesterol levels (especially LDL-cholesterol) in Type 1 and Type 2 diabetic patients with high cholesterol levels despite taking other cholesterol lowering drugs (maximum tolerated dose of statins and with or without other lipid modifying therapy).
Patients will be randomized in a double blinded manner to receive either 75mg of alirocumab in an auto-injector, or placebo in an identical auto-injector, to be self-administered every two weeks for 6 months. Patients randomized to alirocumab, but not achieving adequate lowering in LDL-cholesterol will have their dosage increased to 150 mg after 3 months of treatment, also in a blinded manner.
The study consists of a 3 week screening period, followed by 5 clinic visits and 1 telephone contact over the 6 months treatment period, and a follow-up safety phone call 8 weeks later.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0405
Date of REC Opinion
31 Dec 2015
REC opinion
Further Information Favourable Opinion