Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01173926

First received: July 30, 2010

Last updated: June 28, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 30, 2010

Last Updated Date

June 28, 2012

Start Date ^ICMJE

July 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the glucose infusion rate curve [ Time Frame: from 0 to 6 hours after single-dose (only for NN1250 and NN5401) ] [ Designated as safety issue: No ]
Area under the glucose infusion rate curve [ Time Frame: from 6 to 24 hours after single-dose (only for NN5401 and insulin aspart) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01173926 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Area under the serum insulin NN1250 concentration-time curve [ Time Frame: from 0 to 120 hours after single-dose (only for NN5401 and NN1250) ] [ Designated as safety issue: No ]
Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose (only for NN5401 and insulin aspart) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

Official Title ^ICMJE

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 with NN1250 and insulin aspart in subjects with type 1 diabetes mellitus.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: NN1250
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
Drug: NN5401
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
Drug: insulin aspart
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).

Study Arm (s)

Experimental: A
Intervention: Drug: NN1250
Experimental: B
Intervention: Drug: NN5401
Active Comparator: C
Intervention: Drug: insulin aspart

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 1 diabetes mellitus for at least 12 months
Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive)

Exclusion Criteria:

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial entry
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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01173926

Other Study ID Numbers ^ICMJE

NN5401-3857, U1111-1114-9348, 2010-019641-26

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kirstine Stender-Petersen

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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