Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)

November 30, 2018 updated by: Novo Nordisk A/S

A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes in Inadequate Glycaemic Control on Once or Twice Daily Premixed or Self-mixed Insulin Regimen With or Without OADs (BOOST™: Intensify Premix 1)

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

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

  • Australia
      • Garran, Australia, 2605
        • Novo Nordisk Investigational Site
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Novo Nordisk Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • Novo Nordisk Investigational Site
    • Victoria
      • East Ringwood, Victoria, Australia, 3135
        • Novo Nordisk Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • Novo Nordisk Investigational Site
  • Denmark
      • Gentofte, Denmark, 2820
        • Novo Nordisk Investigational Site
      • Hjørring, Denmark, 9800
        • Novo Nordisk Investigational Site
      • Horsens, Denmark, 8700
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • Svendborg, Denmark, 5700
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Lahti, Finland, 15110
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90100
        • Novo Nordisk Investigational Site
      • Pori, Finland, FI-28100
        • Novo Nordisk Investigational Site
      • Ylitornio, Finland, FI-95600
        • Novo Nordisk Investigational Site
  • India
      • Kolkata, India, 700017
        • Novo Nordisk Investigational Site
      • Mumbai, India, 400016
        • Novo Nordisk Investigational Site
      • New Delhi, India, 110044
        • Novo Nordisk Investigational Site
    • Haryana
      • Karnal, Haryana, India, 132001
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
    • Kerala
      • Trivandrum, Kerala, India, 695011
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 4000021
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600 013
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Pulau Pinang, Malaysia, 10990
        • Novo Nordisk Investigational Site
      • Putrajaya, Malaysia, 62250
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-445
        • Novo Nordisk Investigational Site
      • Bydgoszcz, Poland, 85-822
        • Novo Nordisk Investigational Site
      • Gniewkowo, Poland, 88-140
        • Novo Nordisk Investigational Site
      • Plock, Poland, 09-400
        • Novo Nordisk Investigational Site
      • Rawa Mazowiecka, Poland, 96-200
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 01-809
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 222 22
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 211 52
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 118 83
        • Novo Nordisk Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novo Nordisk Investigational Site
      • Chiayi City, Taiwan, 600
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 231
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10330
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10110
        • Novo Nordisk Investigational Site
      • Chiang Mai, Thailand, 50200
        • Novo Nordisk Investigational Site
  • Turkey
      • Istanbul, Turkey, 34722
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34093
        • Novo Nordisk Investigational Site
      • Kocaeli, Turkey, 41380
        • 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
  • Subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID), with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU), glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before Visit 1
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
  • Treatment with rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
  • 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)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer (except basal cell skin cancer and 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 BID
Drug: insulin degludec/insulin aspart
Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.
EXPERIMENTAL: BIAsp 30 BID
Drug: biphasic insulin aspart 30
Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

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
Rate of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Week 0 to Week 26 + 7 days follow up

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 (ACTUAL)

November 5, 2009

Primary Completion (ACTUAL)

August 23, 2010

Study Completion (ACTUAL)

August 23, 2010

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (ESTIMATE)

November 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3592
  • 2008-005768-15 (EUDRACT_NUMBER)
  • U1111-1111-8545 (OTHER: WHO)

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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