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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT01761318
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Age \> 18 years and \< 70 years
* BMI \> 25 kg/m2
* DM2 treated with metformin, metformin + SU derivative, metformin + SU derivative + insulin, or metformin + insulin for at least 3 months in the maximum tolerable dosage
* HbA1c ≥7% and ≤ 10.0 %
* EGFR \> 60 ml/min
* Normal sitting blood pressure \< 150/85 mm Hg and stable for at least one month
Exclusion Criteria:
* Use of thiazolidinediones (TZD), GLP-1 analogues, DPP-IV inhibitors, fibrates, prednisone, cytostatic or antiretroviral therapy within 6 months prior to the study
* Hereditary lipoprotein disease
* Psychiatric disorders and / or use of antipsychotic or antidepressant drugs at present or in the past
* Hepatic disease (AST/ALT \> 2 times reference values)
* Endocrine disease other than diabetes mellitus type 2
* History or presence of cardiovascular disease
* Any significant chronic disease (e.g. inflammatory bowel disease)
* Any significant abnormal laboratory results found during the medical screening procedure
* Gastrointestinal surgery (e.g. gastric bypass)
* Pregnant woman or a woman who is breast-feeding
* Female of child-bearing potential intending to become pregnant or is not using adequate contraceptive methods while sexually active
* Allergy to intravenous contrast
* Known or suspected hypersensitivity to trial products or related products
* Chronic pancreatitis or previous acute pancreatitis
* Personal history or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia type 2
* Claustrophobia
* Metal implants or other contraindications for MRI
* Recent participation in other research projects within the last 3 months or participation in 2 or more projects in one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01761318
Study Brief:
Protocol Section:
NCT01761318