Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697618

ANA/DCD/046

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Enrollment: 13 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Type 2 diabetes for at least 12 months
• Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
• BMI (body mass index) below 39 kg/m^2
• HbA1c (glycosylated haemoglobin) below 12%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 2 patient groups

BIAsp 30

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic human insulin 30

BHI 30

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic human insulin 30