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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT01638260
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities
* Men or women with type 2 diabetes mellitus
* Insufficiënt glycaemic control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea derivate or during combination therapy with metformin and a sulfonylurea derivate or a thiazolinedione
* HbA1c ≥ 7.0% at screening
* BMI ≥ 25.0 kg/m2 at screening
* Age between 40-75 years
Exclusion Criteria:
* Type 1 diabetes mellitus
* HbA1c ≥ 10% at screening
* Use of GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DDP-4 inhibitor within 3 months prior to screening
* Use of insulin within 3 months prior to screening
* An acute coronary or cerebrovascular event in the previous 3 months at screening
* Chronic heart failure NYHA class IV at screening
* Estimated glomerular filtration rate (eGFR) as per Modification of Diet in Renal Disease (MDRD) \< 30 ml/min/1.73m2 at screening
* Liver disease, defined as alanine or aspartate aminotransferase levels more than 2.5 the upper limit of normal range at screening
* Malignant neoplasm
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or family history of medullary thyroid cancer
* Chronic or acute pancreatitis
* Abuse or dependence of alcohol or drugs (as defined by DSM-IV)
* Any acute condition or exacerbation of chronic condition that would in the investigator's opinion interfere with the study
* Known or suspected hypersensitivity or intolerance to liraglutide
* Known to be uncooperative or noncompliant
* Simultaneous participation in any other clinical study of an investigational product
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01638260
Study Brief:
Protocol Section:
NCT01638260