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Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02568280
Enrollment
42
Registered
2015-10-05
Start date
2015-10-06
Completion date
2016-04-25
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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.

Interventions

DRUGFaster-acting insulin aspart

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

DRUGinsulin aspart

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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Mean change in plasma glucose concentrationFrom 0-1 hour after trial product administration

Secondary

MeasureTime frame
Rate of endogenous glucose productionFrom 0-6 hours after trial product administration
Area under the serum insulin aspart concentration-time curveFrom 0-6 hours after trial product administration

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026