Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01486862

BIASP-1673

Details and patient eligibility

About

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus for at least 12 months
• HbA1c between 7.5-14.5% (inclusive) at screening
• Insulin naïve
• An antidiabetic regimen that has been stable for at least 3 months prior to screening
• An antidiabetic regimen that includes a minimum of 2 OADs

Exclusion criteria

• Use of any insulin preparations within the past 6 months
• Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

BIAsp 30

Experimental group

Treatment:

Drug: biphasic insulin aspart 30