A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin icodec; Insulin glargine U100
Intervention description: Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.; Participants will receive s.c. injections of insulin glargine OD for 16 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine
      doctors can already prescribe) in people with type 2 diabetes. Different ways of switching
      from the insulin which the participants are already on to insulin 287 are also compared. This
      is done to find the best way to switch to insulin 287. The participants will either get
      insulin 287 that they will have to inject once a week or insulin glargine that they will have
      to inject once a day. Which treatment any participant gets is decided by chance. The study
      will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6
      phone calls with the study doctor. At 3 of the clinic visits participants will be asked not
      to eat or drink anything (except for water) in the last 8 hours before the visit. During the
      study, the doctor will ask the participants to: 1) measure their blood sugar every day with a
      blood sugar meter using a finger prick; 2) write down different information in a diary daily
      and return this to their study doctor. 3) wear a medical device (sensor) that measures the
      participants blood sugar all the time for 18 weeks (about 4 months) during the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  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.

        Exclusion criteria:

          -  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.