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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT00123604
Eligibility Criteria:
Inclusion Criteria:
* Age 30-80 years old
* Documented history of type 2 diabetes
* Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
* Stable anti-diabetic regimen throughout the study period
* Body mass index (BMI) between 22-45 kg/m2
* HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
* Screening blood pressure (BP) \> 130/80 (average of 3 sitting measurements), with current medications
Exclusion Criteria:
* Uncontrollable or symptomatic arrhythmias
* Unstable angina
* Sick sinus syndrome or second or third degree heart block
* Decompensated heart failure
* Myocardial infarction (MI) or stroke within 3 months of screening
* Bradycardia
* Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids
* Bronchial asthma or related bronchospastic conditions
* New onset/diagnosed type 2 diabetes (\<3 months)
* Clinically significant renal or liver disease (creatinine \>2.5 mg/dL)
* Endocrine disorders
* Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
* Use of beta-blockers within 3 months of screening
* Use of corticosteroids
* Systemic disease, including cancer, with reduced life expectancy (\<12 months)
* Psychological illness/condition that interferes with comprehension of study requirements
* Use of an investigational drug within 30 days of entry into study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT00123604
Study Brief:
Protocol Section:
NCT00123604