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DiabetesPhase 3BOOST®NCT01680341

Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

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 45 sites in 5 countries.

Completed

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

Official record
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Trial summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
45 sitesin 5 countries
Study dates
31 Aug 2012to 22 Aug 2013
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

  • Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
  • Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
  • Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40 kg/m^2

Who cannot join

  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
  • Life-threatening disease (e.g. cancer)

Trial locations and contacts

45 sites in 5 countries.

45 sites in 5 countries

United States28 sites

  • Novo Nordisk Investigational Site

    Albany, New York, 12206

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Avon, Illinois, 46123

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Buckley, Michigan, 49620

  • Novo Nordisk Investigational Site

    Charleston, South Carolina, 29407

  • Novo Nordisk Investigational Site

    Crystal Lake, Illinois, 60012

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75251

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76132

  • Novo Nordisk Investigational Site

    Goodyear, Arizona, 85395

  • Novo Nordisk Investigational Site

    Greenbrae, California, 94904

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana, 46254

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin, 53144

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34741

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey, 08648

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina, 29572

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Olympia, Washington, 98502

  • Novo Nordisk Investigational Site

    Plantation, Florida, 33324

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    Slidell, Louisiana, 70461-4231

  • Novo Nordisk Investigational Site

    Spring Valley, California, 91978

  • Novo Nordisk Investigational Site

    St. Petersburg, Florida, 33709

  • Novo Nordisk Investigational Site

    Suwanee, Georgia, 30024

  • Novo Nordisk Investigational Site

    Tacoma, Washington, 98405

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08755-8050

  • Novo Nordisk Investigational Site

    Waltham, Massachusetts, 02453

Other trials in United States

Germany6 sites

  • Novo Nordisk Investigational Site

    Erdmannhausen, 71729

  • Novo Nordisk Investigational Site

    Münster, 48145

  • Novo Nordisk Investigational Site

    Neuwied, 56564

  • Novo Nordisk Investigational Site

    Pohlheim, 35415

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

Other trials in Germany

Turkey (Türkiye)5 sites

  • Novo Nordisk Investigational Site

    Antalya, 07050

  • Novo Nordisk Investigational Site

    Denizli, 20070

  • Novo Nordisk Investigational Site

    Gaziantep, 27070

  • Novo Nordisk Investigational Site

    Hatay, 31040

  • Novo Nordisk Investigational Site

    Istanbul, 34752

Other trials in Turkey (Türkiye)

Algeria3 sites

  • Novo Nordisk Investigational Site

    Algiers, 16000

  • Novo Nordisk Investigational Site

    Oran, 31000

  • Novo Nordisk Investigational Site

    Tizi Ouzou, 16015

Other trials in Algeria

Malaysia3 sites

  • Novo Nordisk Investigational Site

    Cheras, 56000

  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan, 16150

  • Novo Nordisk Investigational Site

    Kuala Selangor, 46150

Other trials in Malaysia

About this study

Official title: A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

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

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

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

    Also called IDegAsp

    Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.

  • insulin degludec/insulin aspartDrug

    Also called IDegAsp

    Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.

Study groups in NCT01680341
Study groupRoleWhat they receive
IDegAsp SimpleExperimentalNot described
Receives: Drug: insulin degludec/insulin aspart
IDegAsp Step wiseExperimentalNot 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 (7)

  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. Subjects With HbA1c Below 7.0%

    Number of subjects with HbA1c below 7% after 26 weeks of treatment.

    Measured: Week 26

  3. Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia

    Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.

    Measured: Week 26

  4. Incidence of Treatment Emergent Adverse Events (TEAEs)

    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.

    Measured: Weeks 0-28

  5. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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.

    Measured: Weeks 0-27

  6. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period

    Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and 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.

    Measured: From week 16 to end of trial including follow-up (week 27)

  7. Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes

    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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 am.

    Measured: Weeks 0-27

Timeline

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

  1. First posted7 Sep 2012 (estimated)
  2. Study start31 Aug 2012
  3. Primary completion22 Aug 2013
  4. Study completion22 Aug 2013

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
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01680341
Sponsor's protocol ID
NN5401-3941
Other IDs
2012-000373-23, U1111-1127-4114
Acronym
BOOST®
Status last verified
Mar 2018
First submitted
31 Aug 2012
Last updated
2 Apr 2018
Data monitoring committee
No

Publications

  • Bode BW, Buse JB, Fisher M, Garg SK, Marre M, Merker L, Renard E, Russell-Jones DL, Hansen CT, Rana A, Heller SR; BEGIN(R) Basal-Bolus Type 1 trial investigators. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN((R)) Basal-Bolus Type 1): 2-year results of a randomized clinical trial. Diabet Med. 2013 Nov;30(11):1293-7. doi: 10.1111/dme.12243. Epub 2013 Jun 17.

    PubMed 23710902

  • 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

  • Gerety G, Bebakar WM, Chaykin L, Ozkaya M, Macura S, Herslov ML, Behnke T. TREATMENT INTENSIFICATION WITH INSULIN DEGLUDEC/INSULIN ASPART TWICE DAILY: RANDOMIZED STUDY TO COMPARE SIMPLE AND STEP-WISE TITRATION ALGORITHMS. Endocr Pract. 2016 May;22(5):546-54. doi: 10.4158/EP15893.OR. Epub 2015 Dec 31.

    PubMed 26720250

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 45 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 4 inclusion and 5 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Germany, Turkey (Türkiye), Algeria, Malaysia. 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 17 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 NCT01680341, 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 2 Apr 2018.

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