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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT01074268
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes mellitus for at least 12 months
* Current treatment with any basal bolus insulin for at least 12 months
* HbA1c below or equal to 10.0%
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* For Japan only: Minimum age is 20 years
* For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)
Exclusion Criteria:
* Use of any other antidiabetic drug than insulin within the last 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01074268
Study Brief:
Protocol Section:
NCT01074268