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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

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