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

Diabetes Clinical Trial

Official title:

A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524809
• Other study ID #: BIASP-1317
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2012
• Last updated: January 4, 2017
• Start date: January 2001
• Est. completion date: June 2001

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2001
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• biphasic insulin aspart 30
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
• biphasic insulin aspart 70
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Chen JW, Lauritzen T, Christiansen JJ, Jensen LH, Clausen WH, Christiansen JS. Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Diabet Med. 2005 Mar;22(3):27 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin curve 6-14 hours after dinner at day 15			No
Secondary	Area under the serum insulin curve 6-14 hours after dinner at day 1			No
Secondary	Area under the serum insulin curve 0-6 hours after dinner			No
Secondary	Area under the curve 0-24 hours			No
Secondary	Serum insulin			No
Secondary	Apparent t½ (apparent elimination half life)			No
Secondary	Cmax, maximum concentration			No
Secondary	tmax, time to reach Cmax			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk