NL-OMON42569CompletedPhase 3
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. - LPS14355
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi-aventis
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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.
Exclusion Criteria
- •- 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.
Investigators
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