This trial was conducted in Asia, Europe and South America. The aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (HbA1c).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
348
Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
Change in HbA1c (Glycosylated Haemoglobin) - FAS
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Time frame: Week 0, week 20
Change in HbA1c (Glycosylated Haemoglobin) - PP
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.
Time frame: Week 0, week 20
Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)
Estimated mean change from baseline in FPG after 20 Weeks of treatment
Time frame: Week 0, week 20
Number of Treatment Emergent Hypoglycaemic Episodes
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. 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: Week 0 to week 20
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Time frame: Week 0
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
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Novo Nordisk Investigational Site
Capital Federal, Argentina
Novo Nordisk Investigational Site
Capital Federal, Argentina
Novo Nordisk Investigational Site
Chacabuco, Argentina
Novo Nordisk Investigational Site
Córdoba, Argentina
Novo Nordisk Investigational Site
Córdoba, Argentina
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Lanzhou, Gansu, China
Novo Nordisk Investigational Site
Zhengzhou, Henan, China
Novo Nordisk Investigational Site
Dalian, Liaoning, China
...and 31 more locations
Time frame: Week 4
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Time frame: Week 20