A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin icodec; Placebo (insulin 287); Metformin; Dipeptidyl peptidase-4 inhibitors; Insulin glargine; Placebo (insulin glargine)
Intervention description: Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL); Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.; Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.; Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.; Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).; Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Dipeptidyl-Peptidase IV Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine)
      and insulin glargine (a medicine doctors can already prescribe). The study doctors will test
      insulin 287 to see how well it works compared to insulin glargine. The study will also test
      if insulin 287 is safe. The study participants will either get insulin 287 or insulin
      glargine (100 units/mL) - which treatment the participants get is decided by chance. The
      participants will need to inject their selves every day about the same time. Once a week the
      participant will need to take 1 extra injection on the same day of the week. The participants
      will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the
      doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter
      using a finger prick, 2) write down different information in a paper diary daily and return
      this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2
      weeks 5 times 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

          -  HbA1c of 7.0-9.5% (53-80 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): Any metformin formulations greater than
             or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's
             medical record) OR Any metformin formulations greater than or equal to 1500 mg or
             maximum tolerated or effective dose (as documented in subject medical record) with
             Dipeptidyl peptidase-4 inhibitor (DPP4i) (greater than or equal to half of the maximum
             approved dose according to local label or maximum tolerated or effective dose (as
             documented in subject's medical records)

          -  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) less than or equal to 40.0 kg/m^2

        Exclusion Criteria:

          -  Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of
             screening and between screening and randomisation

          -  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

          -  Presently classified as being in New York Heart Association (NYHA) Class IV

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria within the past 90 days prior to the day of
             screening. 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

          -  Anticipated initiation or change in concomitant medications (for more than 14
             consecutive days) 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 randomisation