This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
Change from baseline in HbA1c after 26 weeks of treatment.
Time frame: Week 0, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment
Time frame: Week 0, Week 26
Subjects With HbA1c Below 7.0%
Number of subjects with HbA1c below 7% after 26 weeks of treatment.
Time frame: Week 26
Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia
Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
Time frame: Week 26
Incidence of Treatment Emergent Adverse Events (TEAEs)
A Treatment Emergent Adverse Event (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.
Time frame: Weeks 0-28
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: Weeks 0-27
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
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Novo Nordisk Investigational Site
Goodyear, Arizona, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Greenbrae, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Bradenton, Florida, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Plantation, Florida, United States
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States
Novo Nordisk Investigational Site
Suwanee, Georgia, United States
...and 35 more locations
Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up \[Week 27\]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: From week 16 to end of trial including follow-up (week 27)
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.
Time frame: Weeks 0-27