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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT01071850
Eligibility Criteria:
Inclusion Criteria:
* Subject has been diagnosed with type 2 diabetes
* Subject has a HbA1c value between 6.8 and 9.5%
* Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
* Subject is on a stable diet and exercise program
* Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Exclusion Criteria:
* Subject has type 1 diabetes mellitus
* Subject is using insulin therapy
* Subject has a serum creatinine higher than upper limit of normal
* Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
* Subject has persistent, uncontrolled severe hypertension as indicated by a
systolic blood pressure \>180 mmHg or a diastolic blood pressure of
\>110mmHg
* Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
* Subject is known to have hepatitis or be a carrier of hepatitis B surface
antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
HIV2
* Subject has a history of lactic acidosis
* Subject has a history of drug and alcohol abuse/dependency within last 12
months
* 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 has a symptomatic urinary tract infection or genital infection
* Female subject is lactating
* Subject has an unstable medical or psychiatric illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01071850
Study Brief:
Protocol Section:
NCT01071850