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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT02836704
Eligibility Criteria:
Inclusion criteria :
* Age ≥ 18 and ≤ 70 years.
* Type 2 diabetes patients with diabetes diagnosis at least 2 years.
* Continuous treatment with stable doses of 2-3 OADs, for more than three months prior to randomization, among which metformin ≥1.5 g/day or at maximum tolerated dose
* HbA1c \>7.5% and ≤11%.
* FPG \>9 mmol/L.
* BMI ≥25 and ≤40 kg/m\^2.
* Ability and willingness to perform self-monitoring of blood glucose using the Sponsor-provided glucose meter and to complete the patient diary.
* Willingness and ability to comply with the study protocol.
* Signed informed consent obtained prior any study procedure.
Exclusion criteria:
* Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
* History of hypoglycemia unawareness.
* Unexplained hypoglycemia in the past 6 months.
* Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method).
* Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma).
* History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the previous 12 months.
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination or disease history record, in the 2 years prior to study entry.
* Impaired renal function defined as, but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (\>2 g/day).
* Active liver disease (alanine transaminase \[ALT\] greater than two times the upper limit of the reference range, as defined by the local laboratory).
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:
70 Years
Study:
NCT02836704
Study Brief:
Protocol Section:
NCT02836704