NCT02033239

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 9, 2014

Last Update Submit

January 16, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve

    From 0 to 12 hours

Secondary Outcomes (3)

  • Area under the serum insulin aspart concentration-time curve

    From 0 to 12 hours

  • Maximum glucose infusion rate

    Within 0 to 12 hours after dosing

  • Maximum observed serum insulin aspart concentration

    Within 0 to 12 hours after dosing

Study Arms (2)

FIAsp

EXPERIMENTAL

Each subject will be randomised to a treatment sequence consisting of 8 treatment periods

Drug: Faster-acting insulin aspart

NovoRapid®

ACTIVE COMPARATOR

Each subject will be randomised to a treatment sequence consisting of 8 treatment periods

Drug: insulin aspart

Interventions

Faster-acting insulin aspartDRUG

Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).

FIAsp
insulin aspartDRUG

Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).

NovoRapid®

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 18.5-28.0 kg/m\^2 (both inclusive)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (3)

  • Heise T, Stender-Petersen K, Hovelmann U, Jacobsen JB, Nosek L, Zijlstra E, Haahr H. Pharmacokinetic and Pharmacodynamic Properties of Faster-Acting Insulin Aspart versus Insulin Aspart Across a Clinically Relevant Dose Range in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2017 Jun;56(6):649-660. doi: 10.1007/s40262-016-0473-5.

    PMID: 27878566BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 28205039DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

DE(1)