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:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT03531905
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes for 6 months or greater
* Currently taking stable diabetes medication for 3 months or greater
* HbA1c between 7-10%
* LDL-cholesterol greater than 70 mg/dL
* Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication
Exclusion Criteria:
* Body mass index \> 40 kg/m2
* History of documented clinically significant cardiovascular disease
* Fasting triglycerides \> 400 mg/dL
* History of Type 1 diabetes
* Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy
* History of drug or alcohol abuse within 2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03531905
Study Brief:
Protocol Section:
NCT03531905