Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698697
• Other study ID #: NN248-1494
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2012
• Last updated: February 28, 2017
• Start date: September 2, 2002
• Est. completion date: October 18, 2002

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 18, 2002
• Est. primary completion date: October 18, 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant

• Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant

• Body mass index (BMI) 18-26 kg/m^2 (both inclusive)

• Weight 60-90 kg

• Non-smoker

Exclusion Criteria:

• Any condition requiring the regular use of any medication

• Known or suspected allergy to the trial product or related products

• Family history of type 1 diabetes mellitus

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin aspart
Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

Locations

Country	Name	City	State
South Africa	Novo Nordisk Investigational Site	Bloemfontein

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)
Primary	Area under the glucose infusion rate curve
Secondary	Cmax (maximum plasma concentration)
Secondary	Time to reach maximum (tmax)
Secondary	Terminal half-life (t½)
Secondary	Incidence of hypoglycemic events
Secondary	Adverse events
Secondary	GIRmax: The maximal GIR (glucose infusion rate)

External Links

•   Clinical Trials at Novo Nordisk