This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
Treat-to-target dose titration scheme, injection s.c., once daily
Novo Nordisk Investigational Site
Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 16 weeks of treatment
Time frame: Week 0, Week 16
Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 16 weeks of treatment
Time frame: Week 0, Week 16
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Time frame: Week 16
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time frame: Week 0 to Week 16 + 5 days follow up
Rate of Major and Minor Hypoglycaemic Episodes
Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: Week 0 to Week 16 + 5 days follow up
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
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Tablets, 1500-2000 mg/day
Alès, France
Novo Nordisk Investigational Site
Brest, France
Novo Nordisk Investigational Site
La Rochelle, France
Novo Nordisk Investigational Site
Le Creusot, France
Novo Nordisk Investigational Site
Mont-de-Marsan, France
Novo Nordisk Investigational Site
Vénissieux, France
Novo Nordisk Investigational Site
Bad Kreuznach, Germany
Novo Nordisk Investigational Site
Bad Mergentheim, Germany
Novo Nordisk Investigational Site
Dormagen, Germany
Novo Nordisk Investigational Site
Hohenmölsen, Germany
...and 18 more locations
Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).
Time frame: Week 0 to Week 16 + 5 days follow up
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Vital Signs: Diastolic Blood Pressure (BP)
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Vital Signs: Systolic Blood Pressure (BP)
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Vital Signs: Pulse
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Physical Examination
Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Time frame: Week 0, Week 8, Week 16