This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
394
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
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
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes
The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of treatment.
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Novo Nordisk Investigational Site
Algiers, Algeria
Novo Nordisk Investigational Site
Oran, Algeria
Novo Nordisk Investigational Site
Sétif, Algeria
Novo Nordisk Investigational Site
Haskovo, Bulgaria
Novo Nordisk Investigational Site
Lukovit, Bulgaria
Novo Nordisk Investigational Site
Plovdiv, Bulgaria
Novo Nordisk Investigational Site
Rousse, Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria
...and 39 more locations
Time frame: Week 0, week 26
Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks
Responder for HbA1c (\<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: Week 26
Number of Treatment Emergent AEs (Adverse Events)
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. Severity was assessed by investigator.
Time frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product