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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01272804
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 2 diabetes mellitus who are taking metformin only.
* Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only.
* Male and/or female patients (females will be women of non childbearing potential)
* Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs).
* HbA1c between 7.0% and 10.0%.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible).
* Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min
* Any condition possibly affecting drug absorption (eg, gastrectomy)
* History of stroke or transient ischemic attack or myocardial infarction within the past 6 months
* History of coronary artery bypass graft or stent implantation.
* Clinically significant peripheral vascular disease (eg, manifested by claudication).
* Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV.
* One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months.
* Current history of angina/unstable angina.
* Milk or soy allergy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01272804
Study Brief:
Protocol Section:
NCT01272804