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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT01293669
Eligibility Criteria:
Inclusion Criteria:
* Males or postmenopausal/surgically sterile females
* Being treated for T2DM with oral antidiabetic agents (excluding glitazones)
* BMI limit ≤ 38
* Subjects at least 80% compliant on reporting daily SMBG values during washout
* At the end of washout the subject's fasting SMBG is higher than it was at the start of washout and the fasting SMBG ≤ 280.g treated for T2DM with oral antidiabetic agents (excluding glitazones)
Exclusion Criteria:
* Type 1 diabetes mellitus
* Severe complications of T2DM (especially diabetic retinopathy imminently requiring treatment for preserving or restoring vision, diabetic neuropathy with symptomatic orthostatic hypotension, urinary retention, gastric stasis, or pedal ulcers)
* Current treatment with insulin or a glitazone
* Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors
* FSH level of \< 35 IU/L and a LH level \< 25 IU/L except for confirmed surgically sterile women with functioning ovaries
* Significant cardiovascular diseases (including arrhythmia) or congestive heart failure, or severe ischemic disease within the last 3 months prior to Screening, or evidence of stroke, myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty
* History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, CV, GI, or urological disorder; or diagnosis of major depressive disorder; if stable medical disorder, any medical treatment must be stable for last 2 months prior to Screening
* History of diabetic ketoacidosis
* Patients who have an increased red blood cell (RBC) turn-over or thalassemia or anemia
* Known HIV or history of viral hepatitis type B or C
* Systemic infection with TB
* Current or previous use of oral or injectable corticosteroids 3 months prior to screening.
* Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure \> 180 mmHg or a diastolic blood pressure of \> 110 mmHg, with or without treatment
* Subject has had a malignancy in the last 5 years, except for successfully treated basal or squamous cell carcinoma of the skin or of the cervix
* Subject is receiving chemotherapy
* Tobacco user within 4 months prior to Screening
* Smoking cessation therapy within 4 months prior to Screening and/or planned during the study
* Use of prohibited concomitant medications including psychoactive agents
* History within 6 months prior to Screening of alcohol abuse or illicit drug abuse
* Was administered study medication in another clinical trial in the past 3 months prior to Screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01293669
Study Brief:
Protocol Section:
NCT01293669