Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGbiphasic insulin aspart 30
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
DRUGinsulin detemir
Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with type 1 or type 2 diabetes mellitus * Patients uncontrolled on oral antidiabetic drugs * Insulin naïve patients or patients currently on human insulin
Exclusion criteria
* Subjects who are unlikely to comply with protocol requirements * Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study * Subjects on NovoMix® 30 and Levemir™ therapy * Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients * Subjects with hypersensitivity to Levemir™ or to any of the excipients * Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice * Contraindications and warnings specified in the current prescribing information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions. | during 12 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | at the end of the study |
| FBG (Fasting Blood Glucose) | at the end of the study |
| Average (mean) fasting plasma glucose level | at the end of the study |
| Number of minor (including nocturnal) hypoglycaemic events | during 12 months of treatment |
| Number of major (including nocturnal) hypoglycaemic events | during 12 months of treatment |
Countries
Philippines
Outcome results
None listed