Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics 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: NCT01526941
• Other study ID #: BIASP-1318
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2012
• Last updated: January 4, 2017
• Start date: May 2001
• Est. completion date: July 2001

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2001
• Est. primary completion date: July 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics 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. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
• biphasic insulin aspart 70
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady state area under the glucose infusion rate profile, 6-12 hours			No
Secondary	GIRmax, the maximal glucose infusion rate value			No
Secondary	tmax, time to maximum glucose infusion rate value			No
Secondary	area under the glucose infusion rate profile			No
Secondary	Time to 50% of area under the glucose infusion rate profile, 0-12 hours			No
Secondary	Cmax, maximum concentration			No
Secondary	tmax, time to reach Cmax			No
Secondary	Area under the curve			No
Secondary	t½, terminal half-life			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk