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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT01388361
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
* The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
* Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol
Exclusion Criteria:
* Participated in NN1250-3643 and treated with insulin glargine
* Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
* Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
* Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin \[For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula\] at end of treatment in NN1250-3643.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01388361
Study Brief:
Protocol Section:
NCT01388361