This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
274
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
Novo Nordisk Investigational Site
Greenbrae, California, United States
Novo Nordisk Investigational Site
Mission Hills, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Change From Baseline in HbA1c (%)
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 FPG after 26 weeks of treatment
Time frame: Week 0, week 26
Number of Treatment Emergent Hypoglycaemic Episodes
According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) \<3.1 mmol/L(56 mg/dL))
Time frame: During Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes
According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia
Time frame: During Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Time frame: Weeks 0-26
Incidence of Treatment Emergent Adverse Events (TEAE)
A TEAE was defined as an event that has 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 0-26
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Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Slidell, Louisiana, United States
Novo Nordisk Investigational Site
Rockville, Maryland, United States
Novo Nordisk Investigational Site
Buckley, Michigan, United States
Novo Nordisk Investigational Site
Hillsborough, New Jersey, United States
...and 41 more locations