A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1

Diabetes Clinical Trial

Official title:

A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296438
• Other study ID #: NN1218-3872
• Secondary ID: 2010-022222-33U1
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2011
• Last updated: February 20, 2015
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: February 2015
• 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 investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin aspart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus for at least 12 months

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months.

• Body Mass Index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

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

• 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: 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 1

Intervention

Drug:
• Faster-acting insulin aspart
Single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin)
• insulin aspart
Single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight faster-acting insulin aspart injected 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

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin aspart concentration-time curve		from 0-1 hour after trial drug administration	No
Secondary	Area under the serum insulin aspart concentration-time curve		from 0-12 hours after trial drug administration	No

External Links

•   Clinical Trials at Novo Nordisk