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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT00766857
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus
* Male and postmenopausal female
* Age 18 years an above
* Metformin therapy (stable, maximum tolerable dose for 2 months)
* HbA1c 6.5-10%
* Confirmed congestive heart failure (NHYA functional class II-IV)
* Ejection fraction \< 50%
* Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study
Exclusion Criteria:
* Type 1 diabetes mellitus
* Serious renal or liver impairment
* (Receiving treatment for) malignant disease
* Cardiovascular event \< 3 months prior to inclusion
* Acute congestive heart failure
* Any reason for not being able to sustain the imaging studies
* Pacemaker/ICD
* Contraindications for the use of exenatide/ insulin
* Use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening
* Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (\> 2 weeks) within 2 weeks immediately prior to screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00766857
Study Brief:
Protocol Section:
NCT00766857