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

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.

Time frame: Week 0, week 16 of each treatment period.

Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B

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.

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

Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.

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

Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.