Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic human insulin 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520818

BIASP-1075

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

Enrollment: 666 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 diabetes
• Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
• Body mass index (BMI) maximum 40.0 kg/m^2

Exclusion criteria

• History of drug or alcohol dependence
• Impaired hepatic function
• Impaired renal function
• Cardiac disease
• Proliferative retinopathy
• Total daily insulin dose at least 1.80 IU/kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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666 participants in 2 patient groups

BIAsp 50 or 70

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 50

BHI 30

Active Comparator group

Treatment:

Drug: biphasic human insulin 30