A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035371
• Other study ID #: NN1218-3888
• Secondary ID: 2011-002104-32U1
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2014
• Last updated: March 8, 2017
• Start date: January 13, 2014
• Est. completion date: July 24, 2014

Study information

• Verified date: March 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) properties of FIAsp (faster-acting insulin aspart) in children, adolescents and adults with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 24, 2014
• Est. primary completion date: July 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female aged 6-64 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 (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m^2

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)

• Not able or willing to refrain from smoking and use of nicotine substitute products during the 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 (s.c. under the skin)
• insulin aspart
A single dose will be administered subcutaneously (s.c. under the skin)

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Danne T, Biester T, Fath M, Thorsson L, Rikte T, Kordonouri O, Haahr H. Earlier onset and higher early exposure of faster-acting insulin aspart vs. insulin aspart in adults is retained in children and adolescents with T1D. Diabetes 2015; 64 (Suppl. 1): A247 (976-P)

Fath M, Danne T, Biester T, Erichsen L, Kordonouri O, Haahr H. Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2017 Feb 6. doi: 10 — View Citation

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	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours
Secondary	Maximum observed serum insulin aspart concentration		From 0-12 hours

External Links

•   Clinical Trials at Novo Nordisk