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Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Japan

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

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Japanese subject
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index (BMI): 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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

Active Comparator

Arm Label

IDegAsp

BIAsp 30

Arm Description

Outcomes

Primary Outcome Measures

Area under the Glucose Infusion Rate curve after a single dose

Secondary Outcome Measures

Area under the insulin aspart concentration-time curve after a single dose

Full Information

NCT ID

NCT01051102

First Posted

January 15, 2010

Last Updated

February 9, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01051102

Brief Title

Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

Official Title

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 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 Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).

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

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDegAsp

Arm Type

Experimental

Arm Title

BIAsp 30

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

insulin degludec/insulin aspart

Intervention Description

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 30

Intervention Description

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Primary Outcome Measure Information:

Title

Area under the Glucose Infusion Rate curve after a single dose

Time Frame

From 4-12 hours

Secondary Outcome Measure Information:

Title

Area under the insulin aspart concentration-time curve after a single dose

Time Frame

From 0-12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Japanese subject Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index (BMI): 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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

Tokyo

ZIP/Postal Code

130-0004

Country

Japan

12. IPD Sharing Statement

Citations:

Citation

Ikushima I, Hirao K, Sasaki T, Fumiaki K, Clauson P, Roepstorff C, Haahr HL. Glucose lowering effect of IDegAsp in Japanese subjects with type 1 diabetes. 56th Annual Meeting of the Japan Diabetes Society (JDS) 2013; Country: Japan City: Kumamoto

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

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