Clareo Health | Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
