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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT01355718
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol.)
* Patients with type 2 diabetes mellitus
* Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD
* Age: at least 18 years old
* Patients who will be prescribed with insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion by the Physician
Exclusion Criteria:
* Known or suspected allergy to study product(s) or related products
* Previous participation in this study. Participation is defined as screened
* Patients who have been treated with insulin preparations (including insulin analogues) previously
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
* Any other disease or condition that the Physician feels would interfere with study participation or evaluation of results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01355718
Study Brief:
Protocol Section:
NCT01355718