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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir; Drug: biphasic insulin aspart 30

Study type: Observational

Funder types: Industry

Identifiers

NCT00789711

BIASP-3682

Details and patient eligibility

About

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.

Enrollment: 3,131 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,131 participants in 2 patient groups

A

Treatment:

Drug: biphasic insulin aspart 30

B

Treatment:

Drug: insulin detemir