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
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Insulin icodec; Placebo (insulin 287); Metformin; Dipeptidyl peptidase-4 inhibitors; Insulin glargine; Placebo (insulin glargine)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment