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DiabetesPhase 3BOOST™NCT01059812

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

A Phase 3 study testing insulin degludec/insulin aspart and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 46 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
insulin degludec/insulin aspart and biphasic insulin aspart 30
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
46 sitesin 5 countries
Study dates
1 Feb 2010to 23 Dec 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female at least 18 years of age (at least 20 years for Japan)
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body mass index (BMI) maximum 35.0 kg/m^2

Who cannot join

  • Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
  • Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists 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 or squamous cell skin cancer)

Trial locations and contacts

46 sites in 5 countries.

46 sites in 5 countries

Japan16 sites

  • Novo Nordisk Investigational Site

    Chūōku, 104 0061

  • Novo Nordisk Investigational Site

    Imizu-shi, 939 0363

  • Novo Nordisk Investigational Site

    Kamakura-shi, 247 0056

  • Novo Nordisk Investigational Site

    Kashiwara-shi, Osaka, 582-0005

  • Novo Nordisk Investigational Site

    Koriyama-shi, Fukushima, 963-8851

  • Novo Nordisk Investigational Site

    Kumamoto-shi, Kumamoto, 862-0976

  • Novo Nordisk Investigational Site

    Matsumoto-shi, 390 8510

  • Novo Nordisk Investigational Site

    Naha, 900 0032

  • Novo Nordisk Investigational Site

    Naka-shi, Ibaraki, 311-0113

  • Novo Nordisk Investigational Site

    Ōita, 870 0039

  • Novo Nordisk Investigational Site

    Oyama-shi, Tochigi, 323-0022

  • Novo Nordisk Investigational Site

    Sapporo-shi, Hokkaido, 060-0062

  • Novo Nordisk Investigational Site

    Sapporo-shi, Hokkaido, 062-0007

  • Novo Nordisk Investigational Site

    Takatsuki-shi, Osaka, 569-1096

  • Novo Nordisk Investigational Site

    Urasoe-shi,, 901 2104

  • Novo Nordisk Investigational Site

    Yokohama-shi, Kanagawa, 235-0045

Other trials in Japan

South Korea16 sites

  • Novo Nordisk Investigational Site

    Ansan, 152-703

  • Novo Nordisk Investigational Site

    Daegu, 705-717

  • Novo Nordisk Investigational Site

    Daegu, 705-718

  • Novo Nordisk Investigational Site

    Guri-si, 471-101

  • Novo Nordisk Investigational Site

    Gyeonggi-do, 480-717

  • Novo Nordisk Investigational Site

    Incheon, 400-103

  • Novo Nordisk Investigational Site

    Incheon, 405-760

  • Novo Nordisk Investigational Site

    Jeollanamdo, 501-717

  • Novo Nordisk Investigational Site

    Pusan, 602-739

  • Novo Nordisk Investigational Site

    Seongnam-si, 463-707

  • Novo Nordisk Investigational Site

    Seoul, 02447

  • Novo Nordisk Investigational Site

    Seoul, 02841

  • Novo Nordisk Investigational Site

    Seoul, 120-752

  • Novo Nordisk Investigational Site

    Seoul, 134-701

  • Novo Nordisk Investigational Site

    Suwon, 16499

  • Novo Nordisk Investigational Site

    Wŏnju, 220-701

Other trials in South Korea

Malaysia8 sites

  • Novo Nordisk Investigational Site

    Cheras, 56000

  • Novo Nordisk Investigational Site

    Georgetown, Penang, 10450

  • Novo Nordisk Investigational Site

    Johor Bahru, 80100

  • Novo Nordisk Investigational Site

    Klang, Selangor, 41200

  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan, 16150

  • Novo Nordisk Investigational Site

    Kota Kinabalu, 88586

  • Novo Nordisk Investigational Site

    Putrajaya, 62250

  • Novo Nordisk Investigational Site

    Seremban, 70300

Other trials in Malaysia

Taiwan5 sites

  • Novo Nordisk Investigational Site

    Kaohsiung City, 833

  • Novo Nordisk Investigational Site

    Taichung, 404

  • Novo Nordisk Investigational Site

    Tainan, 710

  • Novo Nordisk Investigational Site

    Taipei, 100

  • Novo Nordisk Investigational Site

    Taipei, 112

Other trials in Taiwan

Hong Kong1 site

  • Novo Nordisk Investigational Site

    Shatin, New Territories

Other trials in Hong Kong

About this study

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

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

Being tested
insulin degludec/insulin aspart, biphasic insulin aspart 30
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin degludec/insulin aspartDrug

    Injected subcutaneously twice daily. Dose was individually adjusted.

  • biphasic insulin aspart 30Drug

    Injected subcutaneously twice daily. Dose was individually adjusted.

Study groups in NCT01059812
Study groupRoleWhat they receive
IDegAsp BIDExperimentalNot described
Receives: Drug: insulin degludec/insulin aspart
BIAsp 30 BIDActive comparatorNot described
Receives: Drug: biphasic insulin aspart 30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment

    Change from baseline in HbA1c after 26 weeks of treatment.

    Measured: Week 0, Week 26

Secondary outcomes (4)

  1. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

    Mean of SMPG at 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.

    Measured: Week 26

  2. Rate of Confirmed Hypoglycaemic Episodes

    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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.

    Measured: Week 0 to Week 26 + 7 days follow up

  3. Rate of Nocturnal Confirmed Hypoglycaemic Episodes

    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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

    Measured: Week 0 to Week 26 + 7 days follow up

  4. Change in Body Weight

    Change from baseline in body weight after 26 weeks of treatment.

    Measured: Week 0, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2010 (estimated)
  2. Study start1 Feb 2010
  3. Primary completion23 Dec 2010
  4. Study completion23 Dec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01059812
Sponsor's protocol ID
NN5401-3597
Other IDs
U1111-1111-7210, 101040
Acronym
BOOST™
Status last verified
Nov 2018
First submitted
29 Jan 2010
Last updated
20 Dec 2018
Data monitoring committee
No

Publications

  • Evans M, Gundgaard J, Hansen BB. Cost-Effectiveness of Insulin Degludec/Insulin Aspart Versus Biphasic Insulin Aspart in Patients with Type 2 Diabetes from a Danish Health-Care Perspective. Diabetes Ther. 2016 Dec;7(4):809-823. doi: 10.1007/s13300-016-0195-6. Epub 2016 Aug 23.

    PubMed 27553066

  • Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6.

    PubMed 26612062

  • Taneda S, Hyllested-Winge J, Gall MA, Kaneko S, Hirao K. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. J Diabetes. 2017 Mar;9(3):243-247. doi: 10.1111/1753-0407.12407. Epub 2016 Jul 7.

    PubMed 27059529

  • Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.

    PubMed 29451706

  • Fulcher G, Mehta R, Fita EG, Ekelund M, Bain SC. Efficacy and Safety of IDegAsp Versus BIAsp 30, Both Twice Daily, in Elderly Patients with Type 2 Diabetes: Post Hoc Analysis of Two Phase 3 Randomized Controlled BOOST Trials. Diabetes Ther. 2019 Feb;10(1):107-118. doi: 10.1007/s13300-018-0531-0. Epub 2018 Nov 24.

    PubMed 30474818

  • Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

    PubMed 35044568

  • Kaneko S, Chow F, Choi DS, Taneda S, Hirao K, Park Y, Andersen TH, Gall MA, Christiansen JS; BOOST: Intensify All Trial Investigators. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial. Diabetes Res Clin Pract. 2015 Jan;107(1):139-47. doi: 10.1016/j.diabres.2014.09.026. Epub 2014 Oct 14.

    PubMed 25498130

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/insulin aspart and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 46 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan, South Korea, Malaysia, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment (time frame: Week 0, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01059812, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.

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