A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924637
• Other study ID #: NN1218-3889
• Secondary ID: 2011-000941-19U1
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2013
• Last updated: January 16, 2017
• Start date: August 2013
• Est. completion date: November 2013

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 FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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 more than 5 cigarettes or the equivalent per day)

• Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
A single dose will be administered subcutaneously (under the skin) in the abdomen. Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.
• insulin aspart
A single dose will be administered subcutaneously (under the skin)) in the abdomen. Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.

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 change in plasma glucose concentration		From 0-2 hours after administration
Secondary	Area under the serum insulin aspart concentration-time curve		From 0 to 1 hour
Secondary	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours

External Links

•   Clinical Trials at Novo Nordisk