A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study
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
Male or female, age greater than or equal to 18 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
Subjects fulfilling at least one of the below criteria:
Experienced at least one severe hypoglycaemic episode within the last year prior to screening (according to the American Diabetes Association definition, January 2018)\*
Moderate renal impairment defined as estimated glomerular filtration rate value of 30-59 mL/min/1.73 m\^2 as defined by Kidney Disease Improving Global Outcomes 2012 at screening
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 at screening
Treated with insulin for more than 5 years
Episode of hypoglycaemia (defined a glucose alert value of 70 mg/dL (3.9 mmol/L) or less, i.e., Level 1) within the last 12 weeks prior to screening visit
Treated with any basal insulin greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs:
Metformin
Dipeptidyl peptidase-4 inhibitor
Sodium-glucose co-transporter 2 inhibitor
Alpha-glucosidase-inhibitors (acarbose)
Thiazolidinediones
Marketed oral combination products only including the products listed above
HbA1c less than or equal to 9.5% (80 mmol/mol) at screening confirmed by central laboratory analysis
Body mass index less than or equal to 45 kg/m\^2 \*Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery
Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids)
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and run-in
Clareo Health | A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study