This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
Tablets, 2550 mcg. Administered once daily.
Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
Time frame: After 26 weeks of treatment
9-point Self-measured Plasma Glucose Profiles
Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.
Time frame: After 26 weeks of treatment
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c \<= 6.5% of haemoglobin and HbA1c \< 7% of haemoglobin.
Time frame: After 26 weeks of treatment
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.
Time frame: After 26 weeks of treatment
Number of Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
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Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Novo Nordisk Investigational Site
Buenos Aires, Argentina
Novo Nordisk Investigational Site
Ciudad Autonoma de Bs As, Argentina
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, Argentina
Novo Nordisk Investigational Site
Mar del Plata, Argentina
Novo Nordisk Investigational Site
Bregenz, Austria
Novo Nordisk Investigational Site
Feldkirch, Austria
Novo Nordisk Investigational Site
Traisen, Austria
Novo Nordisk Investigational Site
Vienna, Austria
Novo Nordisk Investigational Site
Wels, Austria
Novo Nordisk Investigational Site
Brno, Czechia
...and 59 more locations
Time frame: Weeks 0-26
Number of Subjects Reporting Treatment Emergent Adverse Events
Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.
Time frame: Weeks 0-26