Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes

• Status: Completed
• Trial end date: 2004-10-22
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.

• Phase: Phase 3
• 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, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Subjects must have been correctly included in and completed BIAsp-1234

Exclusion Criteria:

• Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial

• Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.

• Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)

• Known or suspected allergy to trial product or related products

• Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease