NCT02933853

Brief Summary

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Oct 2016

Longer than P75 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 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

October 14, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

October 13, 2016

Last Update Submit

May 22, 2019

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the serum insulin aspart concentration-time curve

    From 0 to 30 minutes

Secondary Outcomes (3)

  • Maximum observed serum insulin aspart concentration

    Within 0 to 12 hours after dosing

  • Area under the glucose infusion rate curve

    From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)

  • Maximum glucose infusion rate

    Within 0 to 12 hours after dosing

Study Arms (2)

Faster Aspart

EXPERIMENTAL
Drug: Faster-acting insulin aspart

Insulin Aspart

ACTIVE COMPARATOR
Drug: Insulin Aspart

Interventions

Faster-acting insulin aspartDRUG

A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.

Faster Aspart
Insulin AspartDRUG

A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.

Insulin Aspart

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
  • Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
  • HbA1C below or equal to 9.5 % based on central laboratory analysis

You may not qualify if:

  • Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days 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 (1)

  • Pieber TR, Svehlikova E, Brunner M, Halberg IB, Due Thomsen KM, Haahr H. Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 2019 Sep;21(9):2068-2075. doi: 10.1111/dom.13767. Epub 2019 Jun 10.

    PMID: 31069935RESULT

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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 13, 2016

First Posted

October 14, 2016

Study Start

October 14, 2016

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

AU(1)