A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01059812

First received: January 29, 2010

Last updated: May 18, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 29, 2010

Last Updated Date

May 18, 2011

Start Date ^ICMJE

February 2010

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01059812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma glucose profile [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Number of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: after 26 weeks of treatment ] [ 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

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Official Title ^ICMJE

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)

Brief Summary

This trial is conducted in Asia and Japan. The aim of this clinical trial is to compare NN5401 with biphasic insulin aspart 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

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 2

Intervention ^ICMJE

Drug: NN5401
NN5401 injected subcutaneously (under the skin) with the breakfast meal and main evening meal. The dose will be individually adjusted.
Drug: biphasic insulin aspart 30
Biphasic insulin aspart (BIAsp) 30 injected subcutaneously (under the skin) with the breakfast meal and main evening meal. The dose will be individually adjusted.

Study Arm (s)

Experimental: A
Intervention: Drug: NN5401
Active Comparator: B
Intervention: Drug: biphasic insulin aspart 30

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

424

Completion Date

December 2010

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ages eligible for study: 18 years and older, for Japan and Taiwan: minimum age is 20 years.
Type 2 diabetes mellitus for at least 6 months
Treatment with basal human or analogue insulin once or twice a day with or without metformin for at least 3 months or treatment with premixed human or analogue insulin, or self-mixed insulin regimen containing 20-40% fast/rapid-acting component once or twice a day with or without metformin for at least 3 months
HbA1c 7.0-10.0 % (both inclusive)
BMI (Body Mass index) below or equal to 35.0 kg/m2

Exclusion Criteria:

Treatment with oral antidiabetic drugs (except metformin) within the last 8 weeks prior to trial start
Treatment with thiazolidinedione or GLP-1 receptor agonists within 3 months prior to trial start
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer

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

Hong Kong, Japan, Korea, Republic of, Malaysia, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01059812

Other Study ID Numbers ^ICMJE

NN5401-3597, U1111-1111-7210, 101040

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:

Lise Sylvest Helledi, M.Sc, Ph.D

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2011

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

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