Comparison of Two NN1250 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 glargine; insulin degludec; insulin degludec; insulin degludec; metformin
Intervention description: Treat-to-target dose titration scheme, s.c. injection.; Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily; Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily; Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly; Tablets, 1500-2000 mg/day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin, Long-Acting
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia and North America. The aim of this trial is to
      compare two insulin degludec (NN1250, SIBA) 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 maximeum 14
             days within the last 3 months)

          -  Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea
             (SU) (or 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 the summary of product characteristics (SPC) or
             locally approved PI

          -  HbA1c 7.0-11.0 % (both inclusive)

          -  Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive)

        Exclusion Criteria:

          -  Metformin contraindication according to local practice

          -  Thiazolidinedione (TZD) treatment within 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) three
             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 drug