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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697618
• Other study ID #: ANA/DCD/046
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2012
• Last updated: January 3, 2017
• Start date: April 1997
• Est. completion date: November 1998

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board, Dutch Health Care InspectorateUnited Kingdom: Medicines and Healthcare Products Regulatory
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 1998
• Est. primary completion date: November 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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%

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
• biphasic human insulin 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Alphen a/d Rijn
United Kingdom	Novo Nordisk Investigational Site	Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

References & Publications (1)

McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin curve			No
Secondary	Overall shape of the 24 hour serum insulin profile			No
Secondary	Cmax (maximum plasma concentration)			No
Secondary	tmax (time to reach maximum)			No
Secondary	Area under the curve following each injections derived from 24 hours serum insulin profiles			No
Secondary	Overall shape of the 24 hour serum glucose profile			No
Secondary	Serum glucose excursions (EXC)			No

External Links

•   Clinical Trials at Novo Nordisk