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A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

insulin degludec/insulin aspart

biphasic insulin aspart 30

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index 18.0-28.0 kg/m^2 (both inclusive)
HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis

Exclusion Criteria:

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IDegAsp - BIAsp

BIAsp - IDegAsp

Arm Description

Outcomes

Primary Outcome Measures

Area under the Glucose Infusion Rate curve (only for NN5401)

Secondary Outcome Measures

Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)

Full Information

NCT ID

NCT01174303

First Posted

August 2, 2010

Last Updated

February 9, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01174303

Brief Title

A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

Official Title

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric Subjects With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDegAsp - BIAsp

Arm Type

Experimental

Arm Title

BIAsp - IDegAsp

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin degludec/insulin aspart

Intervention Description

Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 30

Intervention Description

Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.

Primary Outcome Measure Information:

Title

Area under the Glucose Infusion Rate curve (only for NN5401)

Time Frame

from 0 to 24 hours after single-dose administration

Secondary Outcome Measure Information:

Title

Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)

Time Frame

from 0 to 24 hours after single-dose administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group) Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

26088815

Citation

Brunner M, Pieber T, Korsatko S, Kojzar H, Svendsen AL, Haahr H. The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes. Drugs Aging. 2015 Jul;32(7):583-90. doi: 10.1007/s40266-015-0272-y.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

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