NCT02568280

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart 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
42

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Oct 2015

Typical duration for phase_1 diabetes

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

First Submitted

Initial submission to the registry

October 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

October 6, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2016

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

October 2, 2015

Last Update Submit

December 7, 2018

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Mean change in plasma glucose concentration

    From 0-1 hour after trial product administration

Secondary Outcomes (2)

  • Rate of endogenous glucose production

    From 0-6 hours after trial product administration

  • Area under the serum insulin aspart concentration-time curve

    From 0-6 hours after trial product administration

Study Arms (2)

Faster aspart

EXPERIMENTAL
Drug: Faster-acting insulin aspart

Insulin aspart

ACTIVE COMPARATOR
Drug: insulin aspart

Interventions

Faster-acting insulin aspartDRUG

Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Faster aspart
insulin aspartDRUG

Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Insulin aspart

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
  • Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
  • Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

You may not qualify if:

  • Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Graz, 8010, Austria

Location

Related Publications (2)

  • Basu A, Pieber TR, Hansen AK, Sach-Friedl S, Erichsen L, Basu R, Haahr H. Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast-acting insulin aspart compared with insulin aspart. Diabetes Obes Metab. 2018 Jul;20(7):1615-1622. doi: 10.1111/dom.13270. Epub 2018 Mar 30.

    PMID: 29493118RESULT

  • Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.

    PMID: 30402720RESULT

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

October 2, 2015

First Posted

October 5, 2015

Study Start

October 6, 2015

Primary Completion

April 25, 2016

Study Completion

April 25, 2016

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

AU(1)