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CompletedNCT02933853Updated May 24, 2019

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

A Phase 1 interventional study of Faster-acting insulin aspart and Insulin Aspart in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Austria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-24.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 61 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Faster Aspart

    Drug: Faster-acting insulin aspart

  • Active comparator
    Insulin Aspart

    Drug: Insulin Aspart

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. Area under the serum insulin aspart concentration-time curve

    Time frame: From 0 to 30 minutes

Secondary outcomes

  1. Maximum observed serum insulin aspart concentration

    Time frame: Within 0 to 12 hours after dosing

  2. Area under the glucose infusion rate curve

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

  3. Maximum glucose infusion rate

    Time frame: Within 0 to 12 hours after dosing

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Graz, 8010, Austria
08

References and documents

Publications

  • 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. PubMed 31069935 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02933853
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 14, 2016
Start date
Oct 14, 2016
Primary completion
Dec 21, 2017
Completion
Dec 21, 2017
Last update
May 24, 2019

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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