Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine; insulin aspart
Intervention description: Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.; Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted.; Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1006.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).

      The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin
      glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without
      pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the
      long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with
      or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

      All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial
      participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

      Subjects who consent to participate in the extension trial (NN1250-3667) will continue to
      receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

      The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension
      period is registered as NN1250-3667.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For MAIN period (NN1250-3582):

          -  Type 2 diabetes mellitus for at least 6 months

          -  Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for
             at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start

          -  HbA1c 7.0-10.0 % (both inclusive)

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m^2

          -  For EXTENSION period (NN1250-3667):

          -  Completion of the 52 week treatment period in NN1250-3582

        Exclusion Criteria:

          -  For MAIN period (NN1250-3582):

          -  Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus
             within 3 months

          -  Cardiovascular disease within the last 6 months

          -  Uncontrolled treated/untreated severe hypertension

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures

          -  Cancer and medical history of cancer