A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992588
• Other study ID #: NN1218-3890
• Secondary ID: 2011-000913-37U1
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2013
• Last updated: November 7, 2016
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• 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 the trial is to compare 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) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female aged 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 (BMI) 18.5-28.0 kg/m^2 (both inclusive)

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

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

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
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion. The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
• insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion. The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Heise T, Zijlstra E, Nosek L, Rikte T, Haahr H. Pharmacological properties of faster-acting insulin aspart versus insulin aspart in patients with type 1 diabetes using continuous subcutaneous insulin infusion: a randomised, double-blind, crossover trial. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve		From 0 to 30 minutes	No
Secondary	CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve		From 0 to 1 hour	No
Secondary	CSII bolus related baseline corrected area under the glucose infusion rate curve		From 0 to 1 hour	No

External Links

•   Clinical Trials at Novo Nordisk