An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: biphasic insulin aspart 30
* Drug: insulin detemir


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* 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<br>* Other names: BIASP;|
| B<br> | Drug: insulin detemir<br>* Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions. |  | during 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |