A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin icodec; Insulin Glargine
Intervention description: Administered subcutaneously SC once weekly. Starting dose will be 70U.; Administered subcutaneously SC once daily.The starting dose will be 10U.
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: 205.0
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 changing the
      dose of insulin 287 are also compared. This is done to find the best way to change the dose
      of insulin 287. Participants will either get insulin 287 that they will have to inject once a
      week or insulin glargine that participants will have to inject once a day. Which treatment
      participants get is decided by chance. The study will last for about 5 months (23 weeks).
      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 study doctor will ask participants
      to:

        -  measure blood sugar every day with a blood sugar meter using a finger prick.

        -  write down different information in a diary daily and return this to the study doctor.

        -  wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about
           4 months) during the study.

      Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study
      period.
    

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

          -  HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central
             laboratory

          -  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 plus/minus DPP4i
                  with or without SGLT2i is allowed:

             i) DPP4i (greater than or equal to half of the maximum approved dose according to
             local label or maximum tolerated or effective dose) ii) SGLT2i (greater than or equal
             to half of the maximum approved dose according to local label or maximum tolerated or
             effective dose )

          -  Insulin-naïve. However, short term insulin treatment for a maximum of 14 days prior to
             the day of screening is allowed, as is prior insulin treatment for gestational
             diabetes

          -  Body mass index (BMI) below or equal to 40.0 kg/m^2