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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Faster-acting insulin aspart

insulin aspart

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

6 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FIAsp

NovoRapid®

Arm Description

Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days

Outcomes

Primary Outcome Measures

Area under the serum insulin aspart concentration-time curve

Secondary Outcome Measures

Maximum observed serum insulin aspart concentration

Full Information

NCT ID

NCT02035371

First Posted

January 10, 2014

Last Updated

March 8, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02035371

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 13, 2014 (Actual)

Primary Completion Date

July 24, 2014 (Actual)

Study Completion Date

July 24, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FIAsp

Arm Type

Experimental

Arm Description

Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days

Arm Title

NovoRapid®

Arm Type

Active Comparator

Arm Description

Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Intervention Description

A single dose will be administered subcutaneously (s.c. under the skin)

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

A single dose will be administered subcutaneously (s.c. under the skin)

Primary Outcome Measure Information:

Title

Area under the serum insulin aspart concentration-time curve

Time Frame

From 0 to 12 hours

Secondary Outcome Measure Information:

Title

Maximum observed serum insulin aspart concentration

Time Frame

From 0-12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

12. IPD Sharing Statement

Citations:

Citation

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)

Results Reference

background

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

Results Reference

background

PubMed Identifier

28165180

Citation

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 Dec;18(8):903-910. doi: 10.1111/pedi.12506. Epub 2017 Feb 6.

Results Reference

result

PubMed Identifier

28205039

Citation

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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