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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00537303
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus for more than 6 months
* HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
* BMI (Body Mass Index) less than 40 kg/m2
* Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
* Treatment with one to 3 OADs
Exclusion Criteria:
* Known or suspected allergy to trial products or related products
* Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
* Previous participation in any trial including this for the last 6 months
* Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00537303
Study Brief:
Protocol Section:
NCT00537303