Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics 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

NCT00791895

BIASP-2174

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus for at least 12 months
• HbA1c: 7.5-10.0%
• An antidiabetic regimen that has been stable for at least 3 months
• Able and willing to perform SMBG testing as per protocol

Exclusion criteria

• Use of any insulin preparations other than NPH or glargine within the past 6 months
• Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
• Known or suspected allergy to trial product or agents related to trial product

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

A

Experimental group

Treatment:

Drug: biphasic insulin aspart 30