Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01524809

BIASP-1317

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 12 months
• Currently on a multiple dose insulin regimen
• HbA1c maximum 12.0%
• BMI (body mass index) below 35 kg/m^2
• Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion criteria

• Treatment with insulin aspart within the last 14 days prior to this trial
• The receipt of any investigational drug within the last 30 days prior to this trial
• Total daily insulin dose at least 1.8 U/kg
• A history of drug abuse or alcohol dependence within the last 5 years
• Impaired hepatic function
• Impaired renal function
• Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
• Cardiac disease
• Severe, uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 70

Treatment period 2

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 70