Comparison of Single Dose and Steady State Pharmacodynamics 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 30; Drug: biphasic insulin aspart 70

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526941

BIASP-1318

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least 12 months
• Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
• BMI (Body Mass Index) maximum 35 kg/m^2
• Able and willing to perform self-blood glucose monitoring

Exclusion criteria

• 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/day
• Currently being treated with insulin aspart products
• A history of drug abuse or alcohol dependence within the last 5 years
• Impaired hepatic function
• Impaired renal function
• Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
• Cardiac problems
• Severe, uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 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