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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467375

BIASP-1361

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

89 participants in 1 patient group

A

Experimental group

Treatment:

Drug: biphasic insulin aspart