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.
- Conditions
- hypercholesterolemia-high cholesterol1001108210018424
- Registration Number
- NL-OMON42569
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
I 01. Patients with Type 1 or Type 2 diabetes treated with insulin with LDL >=70 mg/dL, not adequately controlled by a stable, maximum dose/regimen of statin that is tolerated by the patient .
I 02. Patients >=18 years of age..
I 03. Patients diagnosed with Type 1 or Type 2 diabetes at least one year prior to the screening
visit (Week -3).
I 04. Glycosylated hemoglobin (HbA1c) <10% (Week -3)
I 05. Patients with documented history of CVD (including CHD and/or CHD risk equivalents)
and/or at least one additional CV risk factor.
- Plans to initiate new LMT during the course of the study or to modify the dose of the current LMT.
- Not on a stable dose of LMT for at least 4 weeks prior to the screening visit or from screening to randomization.
- Use of nutraceutical products or over-the-counter therapies that may affect lipids which
have not been at a stable dose for at least 4 weeks prior to the screening visit or between screening and randomization visits.
- Use of red yeast rice products within 4 weeks of the screening visit or between screening and randomization visits.
- Not on a stable insulin dose for at least 3 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Percent change in calculated LDL-C from baseline to Week 24 in the<br /><br>intent-to-treat (ITT) population.<br /><br>- Safety parameters, adverse events of special interest, product complaints,<br /><br>laboratory data, vital signs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Percent change in calculated LDL-C from baseline to Week 24, using all LDL-C<br /><br>values during the efficacy treatment period.<br /><br>- Absolute change in HbA1c/FGP/insuline use from baseline to Weeks 12 and 24</p><br>