Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; insulin degludec/insulin aspart; biphasic insulin aspart; metformin
Intervention description: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily; Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily; Treat-to-target dose titration scheme, injection s.c., twice daily; Tablets, 1500-2000 mg/daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble
      Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each
      other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive
      subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. (Trial-related
             activities are any procedure that would not have been performed during normal
             management of the subject.)

          -  Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months
             (no previous insulin treatment or previous short term insulin treatment maximum 14
             days within the last 3 months)

          -  Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea,
             other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase
             inhibitors for at least 2 months at a stable maximally tolerated dose or at least half
             maximally allowed dose according to locally approved summary of product
             characteristics (SPC)

          -  HbA1c, 7.0-11.0 % (both inclusive)

          -  Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive)

        Exclusion Criteria:

          -  Metformin contraindication according to local practice

          -  Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1

          -  Any systemic treatment with products, which in the investigator's opinion could
             interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3
             months prior to randomisation

          -  Subject has a clinically significant, active (during the past 12 months) disease of
             the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system
             (except for conditions associated with type 2 diabetes) that, in the opinion of the
             investigator, may confound the results of the trial or pose additional risk in
             administering trial product