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

Novo Nordisk A/S1 site in 1 country3,131 target enrollmentNovember 2008

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventionsbiphasic insulin aspart 30 insulin detemir

Drugsbiphasic insulin aspart 30 insulin detemir

Overview

Phase: Not Applicable
Intervention: biphasic insulin aspart 30
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 3131
Locations: 1
Primary Endpoint: Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

August 2009

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: biphasic insulin aspart 30

B

Intervention: insulin detemir

Outcomes

Primary Outcomes

Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.

Time Frame: during 12 months of treatment

Secondary Outcomes

HbA1c(at the end of the study)
FBG (Fasting Blood Glucose)(at the end of the study)
Number of minor (including nocturnal) hypoglycaemic events(during 12 months of treatment)
Average (mean) fasting plasma glucose level(at the end of the study)
Number of major (including nocturnal) hypoglycaemic events(during 12 months of treatment)