Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BOOST™)

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01087606

First received: March 15, 2010

Last updated: February 23, 2011

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2010

Last Updated Date

February 23, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Adverse events and number of hypoglycaemic episodes [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Adverse events and number of hypoglycaemic episodes [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01087606 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HbA1c change from baseline [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension) ] [ Designated as safety issue: No ]
Fasting plasma glucose (FPG) [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

HbA1c change from baseline [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension ] [ Designated as safety issue: No ]
Fasting plasma glucose (FPG) [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

Official Title ^ICMJE

An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

Brief Summary

This trial is conducted in Europe, Oceania and in the United States of America (USA).

The aim of this clinical trial is to compare the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart in type 1 diabetes.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: NN5401
NN5401 injected subcutaneously (under the skin) with a meal. The dose will be individually adjusted.
Drug: insulin detemir
Insulin detemir injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
Drug: insulin aspart
Insulin aspart is injected subcutaneously (under the skin) with the remaining meals. The dose will be individually adjusted.
Drug: insulin aspart
Insulin aspart is injected subcutaneously (under the skin) with the meals. The dose will be individually adjusted

Study Arm (s)

Experimental: A
Interventions:
- Drug: NN5401
- Drug: insulin aspart
Active Comparator: B
Interventions:
- Drug: insulin detemir
- 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

377

Completion Date

December 2010

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion Criteria:

Anticipated significant lifestyle changes during the trial
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Denmark, France, Israel, Poland, Puerto Rico, Romania, Russian Federation, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01087606

Other Study ID Numbers ^ICMJE

NN5401-3645, 2009-013412-13, U1111-1113-2475

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kit Maria Truelsen

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2010

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

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