Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

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

Treatments: Drug: biphasic human insulin; Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467323

ANA/DCD/038

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
• Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
• Body mass index (BMI) below or equal to 35.0 kg/m^2
• HbA1c below or equal to 11.0%

Exclusion criteria

• Total daily insulin dose at least 1.4 IU/kg
• Treatment with oral hypoglycaemic agents within the month prior to inclusion
• Recurrent severe hypoglycaemia (as judged by the investigator)
• Active proliferative retinopathy
• Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
• History of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: biphasic insulin aspart

B

Active Comparator group

Treatment:

Drug: biphasic human insulin