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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01353469
Eligibility Criteria:
Inclusion criteria:
* Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (OAD)
* Signed written informed consent
Exclusion criteria:
* HbA1c \<7% or HbA1c \>10% at screening
* No self-monitoring of blood glucose within 3 months prior to screening visit
* Premix insulin treatment for less than 3 months. Insulins other than premix insulin treatment within 3 months prior to screening visit
* In case of treatment with OAD, treatment with a stable OAD dose and regimen for less than 3 months prior to screening visit
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:
75 Years
Study:
NCT01353469
Study Brief:
Protocol Section:
NCT01353469