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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00318656
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 40 to 80 years
* Diagnosis of type 2 diabetes mellitus for at least 6 months
* Body mass index (BMI) ≥25kg/m2
* 7%≥HbA1c ≤ 9% at visit 2
* Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1
* Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures
* Written informed consent
Exclusion Criteria:
* Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening
* Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure
* Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis
* Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1
* Subjects with a history of severe hypoglycaemia
* Anemia defined by haemoglobin concentration \<11.0g/dL for males or \<10.0g/dL for females
* Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females
* Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase \>2.5 times the upper limit of the normal reference range)
* Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
* Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
* Female who are lactating, pregnant, or planning to become pregnant
* Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...)
* Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study
* Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
* Subjects not willing to comply with the procedures described in this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00318656
Study Brief:
Protocol Section:
NCT00318656