Comparison of Two NN5401 Formulations Versus Insulin Glargine, 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; insulin glargine; metformin
Intervention description: Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily; Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily; Treat-to-target dose titration scheme, injection s.c., once daily; Tablets, 1500-2000 mg/day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
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 (SIAC,
      insulin degludec/insulin aspart) formulations with each other and with insulin glargine, 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 month at a stable maximum tolerated dose or at least half
             maximum 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) treatments within the previous three 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
             that, in the opinion of the investigator, may confound the results of the trial or
             pose additional risk in administering trial product