Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02642159
Eligibility Criteria:
Inclusion criteria:
* Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.
* 18 years of age or more.
* Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
* Non-HDL-C of 100 mg/dL or greater.
* Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
* Stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).
* No change in weight of more than 5 kg within the prior 3 months.
* On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.
Exclusion criteria:
* Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.
* Currently drinking more than 2 standard alcoholic drinks per day.
* Body Mass Index (BMI) \>45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.
* Glycosylated hemoglobin (HbA1c) 9% or greater.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02642159
Study Brief:
Protocol Section:
NCT02642159