A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

• Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period [ Time Frame: Week 0, week 16 of each treatment period. ]
  Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
• Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B [ Time Frame: Week 16, week 20 ]
  SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
• Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period [ Time Frame: Week 0, week 16, week 32 ]
  Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.
• Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B [ Time Frame: Week 16, week 20 ]
  Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.
• Number of Adverse Events (AEs) [ Time Frame: From baseline to the end of each 16 week treatment period. ]
  Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.

• Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period [ Time Frame: Week 0, week 16, week 32 ]
• Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B [ Time Frame: Week 16, week 20 ]
• Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period [ Time Frame: Week 0, week 16, week 32 ]
• Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B [ Time Frame: Week 16, week 20 ]
• Number of Adverse Events (AEs) [ Time Frame: From the start of the run-in period (week -16 (visit 2)) to the follow-up visit (week 33) ]

• Diabetes
• Diabetes Mellitus, Type 2

• Drug: insulin degludec
  Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
• Drug: insulin glargine
  Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

• Experimental: IDeg followed by IGlar
  Interventions:

  • Drug: insulin degludec
  • Drug: insulin glargine
• Experimental: IGlar followed by IDeg
  Interventions:

  • Drug: insulin degludec
  • Drug: insulin glargine

• Warren M, Chaykin L, Jabbour S, Sheikh-Ali M, Hansen CT, Rasmussen S, Norwood P. Efficacy, patient-reported outcomes (PRO) and safety of insulin degludec U200 vs insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Diabetes 2015; Suppl. 1 (64): A266 (Abstract 1040-P)
• Warren M., Chaykin L.B., Jabbour S.,Sheikh-Ali M., Hansen C.T., Nielsen T.S.S., Norwood P.. Efficacy, patient-reported outcomes (PRO) and safety of insulin degludec U200 vs insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Diabetologia 2015; 58 (Suppl. 1): S468: (Abstract 968)
• Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, Hansen CT, Nielsen TSS, Norwood P. Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin. Clin Diabetes. 2017 Apr;35(2):90-95. doi: 10.2337/cd15-0058.

Inclusion Criteria:

• Type 2 diabetes
• Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
• Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
• Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria:

• Current treatment with insulin other than insulin glargine in vials
• Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
• Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
• Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)