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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT01630369
Eligibility Criteria:
Inclusion criteria :
* T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs
* Males and Female \> 18 years
* HbA1c \> 7.5%
* Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire
* It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment
Exclusion criteria :
* Type 1 diabetes
* Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)
* Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult
* Patient planning a pregnancy now or in the next 6 months
* The patient is participating in another clinical study now or in the last 28 days prior to Visit 1
* The patient is a drug user (currently or in the past)
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:
NCT01630369
Study Brief:
Protocol Section:
NCT01630369