A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455142
• Other study ID #: NN1045-3834
• Secondary ID: 2011-001569-42U1
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2011
• Last updated: February 19, 2015
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer

• Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)

• HbA1c below or equal to 9.5% by central laboratory analysis

Exclusion Criteria:

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)

• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence 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:
• insulin degludec/insulin aspart
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin degludec concentration-time curve		From 0 to 120 hours after single-dose (SD)	No
Primary	Maximum observed serum insulin degludec concentration		After single-dose (within 0 to 120 hours after dosing)	No
Primary	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours after single-dose	No
Primary	Maximum observed serum insulin aspart concentration		After single-dose (within 0 to 12 hours after dosing)	No
Secondary	Area under the glucose infusion rate curve		From 0 to 26 hours after single-dose	No
Secondary	Maximum glucose infusion rate		After single-dose (within 0 to 120 hours after dosing)	No

External Links

•   Clinical Trials at Novo Nordisk