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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT00655200
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
* Newly diagnosed insulin naive patients
* Patients currently on human insulin or on basal insulin
* Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
* Usage should be in accordance with the current prescribing information (See attached prescribing information)
Exclusion Criteria:
* Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
* Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
* Pregnant women, those planning to become pregnant, or women who are breastfeeding
* Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
* Children below 6 years old
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
6 Years
Study:
NCT00655200
Study Brief:
Protocol Section:
NCT00655200