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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00359112
Eligibility Criteria:
Inclusion criteria:
* Body mass index \> or = to 25 kg/m2.
* HbA1c \> or =7% and \< or =10% at screening.
* FPG \> or = 7.0mmol/L (126mg/dL) at visit 2.
* Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
* Female subjects must be postmenopausal or using effective contraceptive measures.
Exclusion criteria:
* Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
* Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
* Subjects with a history of severe hypoglycaemia.
* Renal disease or renal dysfunction.
* Presence of clinically significant hepatic disease.
* Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
* Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00359112
Study Brief:
Protocol Section:
NCT00359112