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DiabetesPhase 3BOOST™NCT01513590

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec/insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 49 sites in 10 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 Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
394 participants
Where
49 sitesin 10 countries
Study dates
16 Jan 2012to 19 Nov 2012
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

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
  • Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
  • Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days
  • Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
  • HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40.0 kg/m^2

Who cannot join

  • Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
  • Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
  • Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial products or related products

Trial locations and contacts

49 sites in 10 countries.

49 sites in 10 countries

Bulgaria7 sites

  • Novo Nordisk Investigational Site

    Haskovo, 6300

  • Novo Nordisk Investigational Site

    Lukovit, 5770

  • Novo Nordisk Investigational Site

    Plovdiv, 4002

  • Novo Nordisk Investigational Site

    Rousse, 7000

  • Novo Nordisk Investigational Site

    Sofia, 1233

  • Novo Nordisk Investigational Site

    Sofia, 1431

  • Novo Nordisk Investigational Site

    Sofia, 1606

Other trials in Bulgaria

Ukraine7 sites

  • Novo Nordisk Investigational Site

    Dnipro, 49023

  • Novo Nordisk Investigational Site

    Kyiv, 04114

  • Novo Nordisk Investigational Site

    Lviv, 79010

  • Novo Nordisk Investigational Site

    Poltava, 36003

  • Novo Nordisk Investigational Site

    Poltava, 36011

  • Novo Nordisk Investigational Site

    Vinnytsia, 21010

  • Novo Nordisk Investigational Site

    Zhytomyr, 10002

Other trials in Ukraine

Germany6 sites

  • Novo Nordisk Investigational Site

    Bochum, 44869

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386

  • Novo Nordisk Investigational Site

    Völklingen, 66333

  • Novo Nordisk Investigational Site

    Wangen, 88239

Other trials in Germany

Croatia5 sites

  • Novo Nordisk Investigational Site

    Karlovac, 47000

  • Novo Nordisk Investigational Site

    Osijek, 31 000

  • Novo Nordisk Investigational Site

    Rijeka, 51 000

  • Novo Nordisk Investigational Site

    Zadar, 23000

  • Novo Nordisk Investigational Site

    Zagreb, 10000

Other trials in Croatia

Poland5 sites

  • Novo Nordisk Investigational Site

    Bialystok, 15-445

  • Novo Nordisk Investigational Site

    Lublin, 20-044

  • Novo Nordisk Investigational Site

    Lublin, 20-538

  • Novo Nordisk Investigational Site

    Mazowieckie, 09-400

  • Novo Nordisk Investigational Site

    Warsaw, 02-507

Other trials in Poland

Romania5 sites

  • Novo Nordisk Investigational Site

    Bucharest, 020614

  • Novo Nordisk Investigational Site

    Buzău, 120203

  • Novo Nordisk Investigational Site

    Galati, 800578

  • Novo Nordisk Investigational Site

    Oradea, Bihor County, 410469

  • Novo Nordisk Investigational Site

    Sibiu, 550176

Other trials in Romania

Turkey (Türkiye)5 sites

  • Novo Nordisk Investigational Site

    Antalya, 07058

  • Novo Nordisk Investigational Site

    Istanbul, 34096

  • Novo Nordisk Investigational Site

    Istanbul, 34890

  • Novo Nordisk Investigational Site

    Istanbul

  • Novo Nordisk Investigational Site

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Czechia4 sites

  • Novo Nordisk Investigational Site

    Brno, 65691

  • Novo Nordisk Investigational Site

    Hradec Králové, 50005

  • Novo Nordisk Investigational Site

    Prague, 100 00

  • Novo Nordisk Investigational Site

    Prague, 128 08

Other trials in Czechia

Algeria3 sites

  • Novo Nordisk Investigational Site

    Algiers, 16000

  • Novo Nordisk Investigational Site

    Oran, 31000

  • Novo Nordisk Investigational Site

    Sétif, 19000

Other trials in Algeria

Slovakia2 sites

  • Novo Nordisk Investigational Site

    Bratislava, 821 02

  • Novo Nordisk Investigational Site

    Košice, 040 01

Other trials in Slovakia

About this study

Official title: A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)

This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.

Being tested
insulin degludec/insulin aspart
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

    Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.

Study groups in NCT01513590
Study groupRoleWhat they receive
IDegAsp BIDExperimentalNot described
Receives: Drug: insulin degludec/insulin aspart
BIAsp 30 BIDActive comparatorNot described
Receives: Drug: insulin degludec/insulin aspart

What is being measured

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

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin)

    Change from baseline in HbA1c after 26 weeks of treatment.

    Measured: Week 0, week 26

Secondary outcomes (6)

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.

    Measured: Week 0, week 26

  2. Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes

    The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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 am.

    Measured: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product

  3. Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes

    The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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.

    Measured: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product

  4. Change From Baseline in Body Weight

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

    Measured: Week 0, week 26

  5. Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks

    Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.

    Measured: Week 26

  6. Number of Treatment Emergent AEs (Adverse Events)

    A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.

    Measured: Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product

Timeline

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

  1. First posted20 Jan 2012 (estimated)
  2. Study start16 Jan 2012
  3. Primary completion19 Nov 2012
  4. Study completion19 Nov 2012

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
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513590
Sponsor's protocol ID
NN5401-3940
Other IDs
2011-001712-61, U1111-1120-5633
Acronym
BOOST™
Status last verified
Mar 2019
First submitted
16 Jan 2012
Last updated
26 Mar 2019
Data monitoring committee
No

Publications

  • Franek E, Haluzik M, Canecki Varzic S, Sargin M, Macura S, Zacho J, Christiansen JS. Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naive adults with Type 2 diabetes. Diabet Med. 2016 Apr;33(4):497-505. doi: 10.1111/dme.12982. Epub 2015 Nov 17.

    PubMed 26435365

  • 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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 49 sites in 10 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 7 inclusion and 7 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Bulgaria, Ukraine, Germany, Croatia, Poland and 5 more countries. 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 From Baseline in HbA1c (Glycosylated Haemoglobin) (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 NCT01513590, which also lists 4 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 26 Mar 2019.

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