Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes (BOOST™)

February 9, 2017 updated by: Novo Nordisk A/S

A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

465

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Osijek, Croatia, 31 000
        • Novo Nordisk Investigational Site
      • Rijeka, Croatia, 51000
        • Novo Nordisk Investigational Site
  • France
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • Besancon, France, 25030
        • Novo Nordisk Investigational Site
      • DAX, France, 40107
        • Novo Nordisk Investigational Site
      • PERPIGNAN cedex, France, 66046
        • Novo Nordisk Investigational Site
      • Paris, France, 75877
        • Novo Nordisk Investigational Site
      • Saint Herblain, France, 44800
        • Novo Nordisk Investigational Site
      • Sète, France, 34200
        • Novo Nordisk Investigational Site
  • India
      • Kanpur, India, 208005
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 015
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Novo Nordisk Investigational Site
      • Belgaum, Karnataka, India, 590001
        • Novo Nordisk Investigational Site
      • Mangalore, Karnataka, India, 575001
        • Novo Nordisk Investigational Site
    • Kerala
      • Thiruvanathapuram, Kerala, India, 695010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 037
        • Novo Nordisk Investigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751019
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 700-721
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 135-239
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03080
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 134-727
        • Novo Nordisk Investigational Site
      • Sungnam, Korea, Republic of, 463-707
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-858
        • Novo Nordisk Investigational Site
      • Tychy, Poland, 43-100
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-911
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-127
        • Novo Nordisk Investigational Site
  • South Africa
      • Benoni, South Africa, 1500
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1818
        • Novo Nordisk Investigational Site
  • Sweden
      • Dalby, Sweden, 240 10
        • Novo Nordisk Investigational Site
      • Göteborg, Sweden, 417 17
        • Novo Nordisk Investigational Site
      • Härnösand, Sweden, 871 82
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
      • Ängelholm, Sweden, 262 91
        • Novo Nordisk Investigational Site
  • Turkey
      • Istanbul, Turkey, 34098
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34718
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34400
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34662
        • Novo Nordisk Investigational Site
      • Kahramanmaras, Turkey, 46000
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33765
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314-2610
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk Investigational Site
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Novo Nordisk Investigational Site
      • Southfield, Michigan, United States, 48075
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, United States, 78681
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn [NPH] insulin) once daily (OD), for at least 3 months
  • Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • BMI maximum 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior to visit 1
  • Current rosiglitazone users
  • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IDegAsp OD
Drug: insulin degludec/insulin aspart
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.
ACTIVE_COMPARATOR: IGlar OD
Drug: insulin glargine
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time Frame: Week 26
Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (ESTIMATE)

January 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3593
  • U1111-1111-7226 (OTHER: WHO)
  • 2008-005767-34 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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