1) To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoproteincholesterol (LDL-C) after 24 weeks of treatment in patients with diabetes treated with insulin and with…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percent change in calculated LDL-C from baseline to Week 24 in the
intent-to-treat (ITT) population.
- Safety parameters, adverse events of special interest, product complaints,
laboratory data, vital signs.
Secondary outcome
- Percent change in calculated LDL-C from baseline to Week 24, using all LDL-C
values during the efficacy treatment period.
- Absolute change in HbA1c/FGP/insuline use from baseline to Weeks 12 and 24
Background summary
More than 380 million people worldwide have diabetes, most of whom will die
from cardiovascular disease (CVD). Compared to people without diabetes, those
with diabetes are at higher risk of developing CVD, develop associated clinical
complications and at an earlier age, and have shortened life expectancy by
about 6 to 7 years. In addition to the high human cost of disease, CVD
contributes greatly to the overall healthcare expenditure in these patients.
Dyslipidemia is a major risk factor for macrovascular complications in
individuals with diabetes.
Especially a high level of LDL-cholesterol contributes significantly to an
increased risk of CVD in diabetics compared to healthy individuals. The
LDL-cholesterol is therefore selected as a primary endpoint for cholesterol,
and is widely accepted as a valid surrogate endpoint.
Research showed that the number of CVDs is reduced significantly when
LDL-cholesterol levels are lowered in diabetics. Guidelines recommend a values
below 1.8 mmol/l in type 1 and type 2 diabetics with a high CVD risk; a value
that is not reached in many patients even though therapy is maximized.
Because of this issue potentially many patients experience additional CVDs.
Therefore blocking PCSK9 binding to the LDL-Receptor can potentially benefit
diabetics with hypercholesterolemia by decreasing their plasma LDL-C levels.
In this high risk group, and besides the Odyssey Outcomes trial, the safety and
efficacy of alirocumab in insulin treated patients is explored.
Study objective
1) To demonstrate the superiority of alirocumab in comparison with placebo in
the reduction of calculated low-density lipoprotein
cholesterol (LDL-C) after 24 weeks of treatment in patients with diabetes
treated with insulin and with hypercholesterolemia at high cardiovascular risk
not adequately controlled on maximally tolerated LDL-C lowering therapy
2) To evaluate the safety and tolerability of alirocumab in patients with
diabetes treated with insulin
Study design
A randomized, double-blind, placebo controlled paralell-group study.
Intervention
-Alirocumab starting dose of 75 mg every 2 weeks until week 12. After week 12
(and if LDL levels not reached) every 2 weeks 150 mg.
-placebo every 2 weeks.
Study burden and risks
The most common side effects of alirocumab reported in previous completed
studies of alirocumab in patients who received at least one dose of alirocumab
include: injection site reactions, itching and flu (upper respiratory
symptoms). None occurred in more than 6% of the 4700 patients.
Kampenringweg 45 E
Gouda 2803PE
NL
Kampenringweg 45 E
Gouda 2803PE
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-000799-92-NL |
| CCMO | NL55043.101.15 |
| Other | U1111-1172-4772 |