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
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- Informed consent obtained
\- Type 1 diabetes mellitus for 12 months or longer
\- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
\- Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
\- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
\- Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
You may not be if
\- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
\- Use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.Premix insulin is not allowed
\- Known proliferative retinopathy or maculopathy requiring acute treatment
\- Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
\- Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or above 100 mmHg for diastolic
\- History of acute or chronic pancreatitis
\- Screening calcitonin value equal to or above 50 ng/L
\- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
\- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
