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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT00607867
Eligibility Criteria:
Inclusion Criteria:
* People with type 2 diabetes mellitus who currently are receiving the maximal dose of metformin monotherapy (2500 mg/day).
* These subjects will have had a stable glycohemoglobin (tGHb) in an unacceptably high range (8-11%) for at least 4 months prior to beginning the study.
* Subjects with tGHB \> 11% (HbA1c \> 10%) will not be recruited into the study.
Exclusion Criteria:
* Hematological abnormalities
* liver disease
* kidney disease
* macroalbuminuria (\>300 mg albumin/24 hours)
* untreated thyroid disease
* congestive heart failure
* angina
* life-threatening malignancies
* proliferative retinopathy
* severe diabetic neuropathy
* peripheral vascular disease
* serious psychological disorders
* a body mass index \> 35
* and a fasting triglyceride of \>400 mg/dl.
* Subjects taking slow-release metformin will not be studied.
* Subjects taking medications other than metformin, known to affect fuel metabolism such as:
* insulin
* the sulfonylureas
* glucagon-like peptide 1 (GLP-1) analogs and metabolic inhibitors
* pramlintide
* prednisone and similar steroids
* thyroid hormone
* antipsychotic medications
* thiazide diuretics
* medroxyprogesterone
* high dose aspirin, also will be excluded.
* If concentrations of serum folate, B12 or iron are low, the subject will be excluded from the study until corrected, i.e. until normal concentrations are recorded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT00607867
Study Brief:
Protocol Section:
NCT00607867