Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01704378

BIASP-1386

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent obtained before any trial-related activities
• Completed the trial BIAsp-1236

Exclusion criteria

• Planned changes in use of any prescription medication that may interfere with glucose regulation
• Known or suspected allergy to trial products or related products
• Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
• Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

BIAsp

Experimental group

Treatment:

Drug: biphasic insulin aspart