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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02954692
Eligibility Criteria:
Inclusion criteria :
* Adult patients with type 2 diabetes mellitus (≥18 years of age).
* Type 2 diabetes mellitus diagnosis ≥1 year.
* Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
* Stable antidiabetic treatment for at least 3 months.
* Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose \[SMBG\]).
* Signed informed consent obtained.
Exclusion criteria:
* Age \<18 years old.
* Type 1 diabetes mellitus.
* Having secondary type 2 diabetes mellitus.
* Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
* History of hypoglycemia unawareness.
* Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
* Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
* Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
* Pregnant or lactating women.
* Participation in another clinical trial.
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:
NCT02954692
Study Brief:
Protocol Section:
NCT02954692