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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00950534
Eligibility Criteria:
Inclusion criteria:
* Diagnosed with type 2 Diabetes Mellitus (T2DM)
* HbA1c \> or = 7.5%, or HbA1c \< or = 10%
* Continuous oral antidiabetic (OAD) treatment for more or equal than three months before randomisation with stable daily doses of one or more OADs (if on two or more OADs, one must be less or equal than half maximum tolerated dose)
* Willing and able to perform blood glucose monitoring using a blood glucose meter
* Willing and able to keep a daily patient diary
* Willing and able to provide written informed consent before enrolment in the study
Exclusion criteria:
* Type 1 diabetes mellitus
* Body mass index (BMI) \> 45 kg/m²
* Works night shifts
* History of ketoacidosis or hyperosmolar hyperglycaemic state
* History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months
* History of congestive heart failure
* Hypoglycaemia unawareness
* Have had more than one episode of hypoglycaemia (per protocol definition) within 24 weeks before screening
* Impaired renal function defined as, but not limited to, serum creatinine \> or = 1.5 mg/dL (133 µmol/L) males or \> or = 1.4 mg/dL (124 µmol/L) females
* Active liver disease (alanine transaminase (ALT) greater than two times the upper limit of the reference range, as defined by the local laboratory)
* Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol
* Had a blood transfusion or severe blood loss within the 3 months before screening, or have known haemoglobinopathy, haemolytic anaemia or sickle cell anaemia
* Current or previous use of insulin
* Known hypersensitivity / intolerance to insulin glargine or any of its excipients
* Have taken exenatide in the six weeks before screening or for a total of 30 days or more in the 24 weeks before screening
* Currently receiving treatment with non-selective -blockers
* Currently receiving chronic (longer than two weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the four weeks preceding the screening visit
* Currently undergoing therapy or planned radiological examinations requiring the administration of contrasting agents for malignancy (other than non-metastatic / early stage basal cell or squamous cell carcinoma).
* Currently participating in another investigational study or recent study participation ending \< 30 days before screening
* Female patients who are pregnant or breastfeeding
* Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be willing to agree to use a medically accepted contraceptive regimen for the duration of the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00950534
Study Brief:
Protocol Section:
NCT00950534