DiabetesPhase 3BOOST™NCT01045447

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

A Phase 3 study testing insulin degludec/insulin aspart and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 65 sites in 9 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, 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). 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 insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 65 sitesin 9 countries
Study dates: Jan 2010to Oct 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

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

Who cannot join

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)

Trial locations and contacts

65 sites in 9 countries.

Country

City, postcode or hospital

65 sites in 9 countries

United States24 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Baltimore, Maryland, 21204
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75235
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314-2610
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
New Port Richey, Florida, 34652
Novo Nordisk Investigational Site
Orlando, Florida, 32804
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33027
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
Southfield, Michigan, 48034
Novo Nordisk Investigational Site
Southfield, Michigan, 48075
Novo Nordisk Investigational Site
Statesville, North Carolina, 28625
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708

Other trials in United States

India8 sites

Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380 015
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560092
Novo Nordisk Investigational Site
Belagavi, Karnataka, 590001
Novo Nordisk Investigational Site
Bhubaneswar, Odisha, 751019
Novo Nordisk Investigational Site
Kanpur, 208005
Novo Nordisk Investigational Site
Mangalore, Karnataka, 575001
Novo Nordisk Investigational Site
Pune, Maharashtra, 411 037
Novo Nordisk Investigational Site
Thiruvanathapuram, Kerala, 695010

Other trials in India

France7 sites

Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Dax, 40107
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Perpignan, 66046
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Sète, 34200

Other trials in France

South Korea6 sites

Novo Nordisk Investigational Site
Busan, 602-715
Novo Nordisk Investigational Site
Daegu, 700-721
Novo Nordisk Investigational Site
Seoul, 03080
Novo Nordisk Investigational Site
Seoul, 134-727
Novo Nordisk Investigational Site
Seoul, 135-239
Novo Nordisk Investigational Site
Sungnam, 463-707

Other trials in South Korea

Turkey (Türkiye)6 sites

Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34400
Novo Nordisk Investigational Site
Istanbul, 34662
Novo Nordisk Investigational Site
Istanbul, 34718
Novo Nordisk Investigational Site
Istanbul
Novo Nordisk Investigational Site
Kahramanmaraş, 46000

Other trials in Turkey (Türkiye)

Sweden5 sites

Novo Nordisk Investigational Site
Ängelholm, 262 91
Novo Nordisk Investigational Site
Dalby, 240 10
Novo Nordisk Investigational Site
Gothenburg, 417 17
Novo Nordisk Investigational Site
Härnösand, 871 82
Novo Nordisk Investigational Site
Stockholm, 171 76

Other trials in Sweden

Poland4 sites

Novo Nordisk Investigational Site
Gdansk, 80-858
Novo Nordisk Investigational Site
Tychy, 43-100
Novo Nordisk Investigational Site
Warsaw, 00-911
Novo Nordisk Investigational Site
Wroclaw, 50-127

Other trials in Poland

South Africa3 sites

Novo Nordisk Investigational Site
Benoni, 1500
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1818
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1827

Other trials in South Africa

Croatia2 sites

Novo Nordisk Investigational Site
Osijek, 31 000
Novo Nordisk Investigational Site
Rijeka, 51000

Other trials in Croatia

About this study

Official title: 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.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/insulin aspart, insulin glargine
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
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.
insulin glargineDrug
Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Study groups in NCT01045447
Study group	Role	What they receive
IDegAsp OD	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart
IGlar OD	Active comparator	Not described Receives: Drug: insulin glargine

What is being measured

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

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 26 weeks of treatment.
Measured: Week 0, Week 26

Secondary outcomes (1)

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

Timeline

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

Jan 2010Oct 2010

First posted11 Jan 2010 (estimated)
Study startJan 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01045447
Sponsor's protocol ID: NN5401-3593
Other IDs: U1111-1111-7226, 2008-005767-34, 2008
Acronym: BOOST™
Status last verified: Feb 2017
First submitted: 8 Jan 2010
Last updated: 20 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.
PubMed 26582052
Kumar S, Jang HC, Demirag NG, Skjoth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28.
PubMed 27027878
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01045447
Acronym / sponsor ID: BOOST™ / NN5401-3593
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 11 Jan 2010 (estimated)
Results: Posted 18 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDegAsp OD	Experimental	Drug: insulin degludec/insulin aspart
IGlar OD	Active comparator	Drug: insulin glargine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludec/insulin aspartTreat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.	Drug	IDegAsp OD
insulin glargineTreat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.	Drug	IGlar OD

Primary outcome

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

1 secondary outcome

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time frame: Week 26

Results and safety

Results posted to the registry on 18 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDegAsp OD	232	196
IGlar OD	233	205

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, Week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	IDegAsp OD n = 230	IGlar OD n = 233
Value	-0.98 (1.01)	-1.00 (1.06)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time frame of 26 weeks + 7 days follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegAsp OD	10 of 230 (4.3%)	51 of 230 (22.2%)	Not reported
IGlar OD	8 of 233 (3.4%)	62 of 233 (26.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26582052Freemantle N, Mamdani M, Vilsboll T, Kongso JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. doi: 10.1007/s13300-015-0142-y. Epub 2015 Nov 18.
Results publication: PubMed 27027878Kumar S, Jang HC, Demirag NG, Skjoth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28.
Derived from this study: PubMed 35044568Yang 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

65 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/insulin aspart and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 65 sites in 9 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 8 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, India, France, South Korea, Turkey (Türkiye) and 4 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 18 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 Glycosylated Haemoglobin (HbA1c) (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 NCT01045447, which also lists 3 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 Mar 2017.