Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520753

BIASP-1074

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Duration of diabetes for longer than 12 months
• Body mass index (BMI) below 35.0 kg/m^2
• HbA1c below 11.0 %
• Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion criteria

• Current treatment with agents affecting glucose metabolism
• History of drug or alcohol dependence
• Impaired hepatic function
• Impaired renal function
• Cardiac disease
• Proliferative retinopathy
• Recurrent severe hypoglycaemia or advanced neuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

BIAsp 70

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 70

BIAsp 70 + BIAsp 50

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 50