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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00676260
Eligibility Criteria:
Inclusion Criteria:
* Stable glycemic control glycosylated hemoglobin between 6.5 and 10%) in the two months prior to the study.
* Type 2 diabetes treated by diet and stable dose of insulin (alone or with metformin) in the three months prior to the study.
* Female patients must have been postmenopausal, had a hysterectomy, or were surgically sterilized.
Exclusion Criteria:
* Has Type 1 diabetes.
* Has an episode of hypoglycemia requiring medical assistance three months prior to the study.
* Has peripheral artery disease (including Raynaud's syndrome) confirmed by an Ankle Brachial Pressure Index less than 0.9.
* Has severe chronic venous insufficiency as evidenced by venous ulceration or subcutaneous serum deposits.
* Has vascular autoimmune disease, had received a renal transplant, or were receiving dialysis.
* Has had heart failure (New York Heart Association I to IV), left ventricular hypertrophy evident from the ECG, or myocardial infarction 12 months prior to start of study.
* Has Subject had uncontrolled hypertension or familial polyposis coli.
* Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
* Non steroidal anti-inflammatory Drugs (except for aspirin at anti-aggregant doses), oral anti-diabetic drugs (except metformin), calcium-channel blockers, and diuretics at anti-edema doses are excluded from the study.
* Treatment with systemic corticosteroids within four weeks prior to enrolment and during the study was not allowed.
* Patients who have taken beta-blockers are to have been on a stable dose for four weeks before entry in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00676260
Study Brief:
Protocol Section:
NCT00676260