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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02568280

Collaborator

(none)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: Faster-acting insulin aspart Drug: insulin aspart	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 6, 2015

Actual Primary Completion Date :

Apr 25, 2016

Actual Study Completion Date :

Apr 25, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Faster aspart	Drug: Faster-acting insulin aspart Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Active Comparator: Insulin aspart	Drug: insulin aspart Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Arm

Intervention/Treatment

Experimental: Faster aspart

Drug: Faster-acting insulin aspart

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

Active Comparator: Insulin aspart

Drug: insulin aspart

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

Outcome Measures

Primary Outcome Measures

Mean change in plasma glucose concentration [From 0-1 hour after trial product administration]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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