A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131246
• Other study ID #: NN1218-3921
• Secondary ID: 2013-002890-23U1
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2014
• Last updated: January 16, 2017
• Start date: May 2014
• Est. completion date: July 2014

Study information

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

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female 18-64 years (both inclusive) at the time of signing informed consent

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Body mass index 18.5-28.0 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 screening

• Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
• insulin aspart
Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean plasma glucose concentration		From 0-6 hours after start of a standardised meal
Secondary	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours after trial product administration

External Links

•   Clinical Trials at Novo Nordisk