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
Male or female, aged 18-75 years (both inclusive) 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.
Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) greater than or equal to 90 days prior to the day of screening.
Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
1. Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical records).
2. Free or fixed combination therapy: Metformin as outlined above with or without dipeptidyl peptidase 4 inhibitors (DPP4i) with or without sodium-glucose cotransporter 2 inhibitors (SGLT2i) is allowed: 1) DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose); 2) SGLT2i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose.
Body mass index (BMI) less than or equal to 40.0 kg/m\^2.
You may not be if
Known or suspected hypersensitivity to trial product(s) or related products.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation.
Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question 8.
Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator.
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
Clareo Health | A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
