A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin degludec; Insulin glargine
Intervention description: Participants will receive insulin degludec U100 subcutaneous (s.c.) injection once daily for 36 weeks. Doses will be adjusted according to the fasting self-measured plasma glucose (SMPG) values. Participants earlier treated with one or more allowed oral antidiabetic drug(s) (OAD(s)), should continue their pre-trial OAD(s) treatment throughout the trial.; Participants will receive insulin glargine U100 s.c. injection once daily for 36 weeks. Doses will be adjusted according to the fasting SMPG values. Participants earlier treated with one or more allowed OAD(s), should continue their pre-trial OAD(s) treatment throughout the trial.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study compares the effect on blood sugar levels of two medicines: insulin degludec and
      insulin glargine in people with type 2 diabetes. Participants will be treated with insulin
      degludec and insulin glargine during two different periods. Which treatment participants get
      first is decided by chance. Both medicines are approved for use in humans and available on
      the market. They can already be prescribed by participants' doctors. Participants will get
      pre-filled insulin pens to inject these insulins with. The study will last for about 41
      weeks. Participants will visit the clinic 13 times and have 27 phone calls with the study
      doctor or study staff. At 12 of the clinic visits they will take blood samples. In order to
      evaluate the changes in participants' blood sugar level over time, participants will be asked
      to wear a small (35 millimetres (mm) x 5 mm) sensor on the back of participants' upper arm 3
      times during the study. Each time participants must wear the sensor for 2 weeks. This sensor
      is called FreeStyle Libre Pro®. It has a very small tip which is 0.4 mm thick and is inserted
      5 mm under participants' skin. Please note that participants will not be able to see the
      sensor readings while wearing it. The study doctor will show participants the readings when
      participants return to the clinic. Participants will be asked to fill in a diary in between
      visits. Participants will have contact with the study doctor or study staff each week. This
      is to adjust the dose of participants' study medicines and to ensure that participants are
      well. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during
      the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age greater than or equal to 18 years 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

          -  Subjects fulfilling at least one of the below criteria:

          -  Experienced at least one severe hypoglycaemic episode within the last year prior to
             screening (according to the American Diabetes Association definition, January 2018)*

          -  Moderate renal impairment defined as estimated glomerular filtration rate value of
             30-59 mL/min/1.73 m^2 as defined by Kidney Disease Improving Global Outcomes 2012 at
             screening

          -  Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's
             questionnaire question 8 at screening

          -  Treated with insulin for more than 5 years

          -  Episode of hypoglycaemia (defined a glucose alert value of 70 mg/dL (3.9 mmol/L) or
             less, i.e., Level 1) within the last 12 weeks prior to screening visit

          -  Treated with any basal insulin greater than or equal to 90 days prior to the day of
             screening with or without any of the following anti-diabetic drugs:

          -  Metformin

          -  Dipeptidyl peptidase-4 inhibitor

          -  Sodium-glucose co-transporter 2 inhibitor

          -  Alpha-glucosidase-inhibitors (acarbose)

          -  Thiazolidinediones

          -  Marketed oral combination products only including the products listed above

          -  HbA1c less than or equal to 9.5% (80 mmol/mol) at screening confirmed by central
             laboratory analysis

          -  Body mass index less than or equal to 45 kg/m^2 *Hypoglycaemia associated with severe
             cognitive impairment requiring external assistance for recovery

        Exclusion Criteria:

          -  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, intermittent bolus insulin treatment for periods of no longer than
             14 days are permitted prior to the day of screening

          -  Anticipated initiation or change in concomitant medications 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 run-in