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 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT02606357
Eligibility Criteria:
Inclusion criteria :
* Patient ≥ 18 years old.
* Male or Female.
* Type 2 diabetes patients.
* Uncontrolled with previous therapy (HbA1c \>7%), evident in HbA1c test within the last 1 month before study entry.
* Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
* Signed informed consent.
* Signed informed consent.
Exclusion criteria:
* Patient not willing or not able to perform self-monitoring blood glucose.
* Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
* Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
* History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
* History of impaired renal function defined as serum creatinine \>135 μmol/L (\>1.525 mg/dL)in men and \>110 μmol/L (\>1.243 mg/dL) in women, evident in testing done in the last 3 months.
* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).
* Treatment with systemic corticosteroid within 3 months prior to study entry.
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
Study:
NCT02606357
Study Brief:
Protocol Section:
NCT02606357