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 Philippines. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Novo Nordisk A/S · Observational
This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 3,131 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.
Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion is eligible for the study, including newly diagnosed subjects who have never received insulin or an insulin analogue before
Exclusion Criteria:
Drug: biphasic insulin aspart 30
Drug: insulin detemir
Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
Also known as: NovoMix® 30, BIASP
Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
Time frame: during 12 months of treatment
HbA1c
Time frame: at the end of the study
FBG (Fasting Blood Glucose)
Time frame: at the end of the study
Average (mean) fasting plasma glucose level
Time frame: at the end of the study
Number of minor (including nocturnal) hypoglycaemic events
Time frame: during 12 months of treatment
Number of major (including nocturnal) hypoglycaemic events
Time frame: during 12 months 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