A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin degludec; insulin degludec
Intervention description: Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.; Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.; Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.
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: 458.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and
      safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin
      degludec in inadequately treated subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current treatment with IGlar (insulin glargine) with or without OADs (oral
             antidiabetic drug). All antidiabetic treatments should have been on-going for at least
             12 weeks prior to randomisation, and doses of OADs should have been stable in this
             period of time. - Please note that a maximum of 3 OADs are allowed during this trial:
             metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors,
             alfa-glucosidaseinhibitors or pioglitazone.

          -  Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for
             at least 26 weeks prior to visit 1 (Screening visit)

          -  HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis

          -  Body mass index (BMI) equal to or below 35 kg/m^2

        Exclusion Criteria:

          -  Any chronic disorder or severe disease which, in the opinion of the Investigator might
             jeopardise subject's safety or compliance with the protocol

          -  Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV;
             myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)

          -  Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL
             for males and higher than or equal to 1.3 mg/dL for females

          -  Current or past (within the last 5 years) malignant neoplasms (except basal cell and
             squamous cell skin carcinoma)

          -  Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
             in a period of 12 weeks prior to randomisation