An observational study in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Slovenia. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Novo Nordisk A/S · Observational
This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 270 is above the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
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Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: biphasic insulin aspart 50
Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
Also known as: NovoMix® 50
Change in HbA1c
Time frame: At 0, 3, 6, 9, 12 months
Percentage of subjects achieving target HbA1c
Time frame: At 0, 3, 6, 9, 12 months
Change in FPG (fasting plasma glucose)
Time frame: At 0, 3, 6, 9, 12 months
Change in PPG (postprandial glucose)
Time frame: At 0, 3, 6, 9, 12 months
Change in number of hypoglycaemic events
Time frame: At 0, 3, 6, 9, 12 months
Change in insulin presentation
Time frame: At 0, 3, 6, 9, 12 months
Dose and number of injections
Time frame: At 0, 3, 6, 9, 12 months
Number of ADRs (adverse drug reaction)
Time frame: At 0, 3, 6, 9, 12 months
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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