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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT05607160
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus (T2DM) with oral antidiabetic drug (OAD) ± Glucagon-like-peptide-1 receptor agonist (GLP-1-RA) ± basal insulin (other than insulin glargine 300 U/ml)
* Age ≥75 years incl. patients from outpatient and inpatient care forms
* Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%
* Inadequate glycaemic control (HbA1c), defined by the treating physician
* Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties
* Signed consent form
Exclusion Criteria:
* Type 1 diabetes mellitus
* Age \<75 years
* Contraindications to insulin glargine 300 U/ml
* Short-acting insulin in medication
* Current participation in clinical research
* Life expectancy \<1 year
* Known alcohol or drug abuse
* Mini Mental State Examination Score ≤19
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT05607160
Study Brief:
Protocol Section:
NCT05607160