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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568280
• Other study ID #: NN1218-3922
• Secondary ID: 2014-004144-35U1
• Status: Completed
• Phase: Phase 1
• Start date: October 6, 2015
• Est. completion date: April 25, 2016

Study information

• Verified date: December 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 25, 2016
• Est. primary completion date: April 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
• insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & 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 as — View Citation

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 Subje — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in plasma glucose concentration		From 0-1 hour after trial product administration
Secondary	Rate of endogenous glucose production		From 0-6 hours after trial product administration
Secondary	Area under the serum insulin aspart concentration-time curve		From 0-6 hours after trial product administration

External Links

•   Clinical Trials at Novo Nordisk