An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Former Serbia and Montenegro. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Novo Nordisk A/S · Observational
This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 2,308 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Type 1 and 2 diabetes
Exclusion Criteria:
Drug: biphasic insulin aspart 30
There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.
Also known as: NovoMix® 30
Change in HbA1c from baseline
Time frame: After 6 months
Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus
Time frame: after 12 weeks and 26 weeks compared to baseline
Change in FPG (glucose variability)
Time frame: after 12 weeks and 26 weeks compared to baseline
Change in PPG (postprandial control)
Time frame: after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections
Time frame: at 12 weeks and 26 weeks of treatment
Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study
Time frame: after 12 weeks and 26 weeks of treatment compared to baseline
Change in body weight and waist circumference
Time frame: at 12 weeks and 26 weeks of treatment compared to baseline
Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits
Time frame: at 12 weeks and 26 weeks of treatment compared to baseline
Number of adverse drug reactions (ADR)
Time frame: after 12 weeks and 26 weeks of treatment
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S