Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin degludec
Intervention description: Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
Dose was individually adjusted.; Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 373.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The aim of this trial is to
      compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in
      subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation
             (visit 2)

          -  Current treatment with basal-only insulin (no prandial insulin) consisting of either
             insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn
             (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit
             2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue
             (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl
             peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or
             combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks
             prior to randomisation (visit 2)

          -  HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central
             laboratory analysis

          -  Body mass index (BMI) below or equal to 45 kg/m^2

          -  Ability and willingness to adhere to the protocol including self-measured plasma
             glucose (SMPG) according to the protocol

        Exclusion Criteria:

          -  Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)

          -  Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12
             weeks prior to randomisation (visit 2)

          -  Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the
             last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial
             physician)

          -  Previous participation in this trial. Participation is defined as randomised.
             Re-screening is allowed once during the recruitment period

          -  Known or suspected hypersensitivity to trial products or related products

          -  The receipt of any investigational drug within 4 weeks prior to randomisation (visit
             2)