DiabetesPhase 3BOOST™NCT01365507

Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

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 42 sites in 7 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 and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to… 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: 276 participants
Where: 42 sitesin 7 countries
Study dates: Jun 2011to Apr 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

Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
BMI (Body Mass Index) below or equal to 45 kg/m^2
Ability and willingness to adhere to the protocol including self measurement of plasma glucose

Who cannot join

Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
Known or suspected hypersensitivity to trial products or related products
The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits

Trial locations and contacts

42 sites in 7 countries.

Country

City, postcode or hospital

42 sites in 7 countries

United States25 sites

Novo Nordisk Investigational Site
Asheboro, North Carolina, 27203
Novo Nordisk Investigational Site
Concord, California, 94520-1926
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, 41017-3464
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Detroit, Michigan, 48235
Novo Nordisk Investigational Site
Eagan, Minnesota, 55123
Novo Nordisk Investigational Site
Houston, Texas, 77070
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Jacksonville, Florida, 32209-6511
Novo Nordisk Investigational Site
Jacksonville, Florida, 32258
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Lubbock, Texas, 79423
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
North East, Maryland, 21901
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33027
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Troy, Michigan, 48085-5524

Other trials in United States

South Korea5 sites

Novo Nordisk Investigational Site
Seoul, 08308
Novo Nordisk Investigational Site
Seoul, 110-746
Novo Nordisk Investigational Site
Seoul, 150-950
Novo Nordisk Investigational Site
Seoul, 158-710
Novo Nordisk Investigational Site
Suwon, 16247

Other trials in South Korea

Turkey (Türkiye)4 sites

Novo Nordisk Investigational Site
Antalya, 07058
Novo Nordisk Investigational Site
Istanbul, 34096
Novo Nordisk Investigational Site
Istanbul, 34718
Novo Nordisk Investigational Site
Istanbul, 34890

Other trials in Turkey (Türkiye)

Malaysia3 sites

Novo Nordisk Investigational Site
Johor Bahru, 80100
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Novo Nordisk Investigational Site
Kuala Selangor, 46150

Other trials in Malaysia

Mexico2 sites

Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44650
Novo Nordisk Investigational Site
Monterrey, 64460

Other trials in Mexico

Thailand2 sites

Novo Nordisk Investigational Site
Bangkok, 10400
Novo Nordisk Investigational Site
Nakhon Ratchasima, 30000

Other trials in Thailand

Puerto Rico1 site

Novo Nordisk Investigational Site
Bayamón, 00961

Other trials in Puerto Rico

About this study

Official title: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)

Conditions: Diabetes, Diabetes Mellitus, Type 2
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
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Study groups in NCT01365507
Study group	Role	What they receive
IDegAsp Simple	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart
IDegAsp Step wise	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart

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 (4)

Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment.
Measured: Week 0, week 26
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Measured: Week 0 to Week 26 + 7 days follow up
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 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: Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of nocturnal 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.
Measured: Week 0 to Week 26 + 7 days follow up

Timeline

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

Jun 2011Apr 2012

First posted3 Jun 2011 (estimated)
Study startJun 2011
Primary completionApr 2012
Study completionApr 2012

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 (2)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: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01365507
Sponsor's protocol ID: NN5401-3844
Other IDs: U1111-1117-0558
Acronym: BOOST™
Status last verified: Feb 2017
First submitted: 31 May 2011
Last updated: 17 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Park SW, Bebakar WM, Hernandez PG, Macura S, Herslov ML, de la Rosa R. Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST(R) : SIMPLE USE). Diabet Med. 2017 Feb;34(2):174-179. doi: 10.1111/dme.13069. Epub 2016 Mar 6.
PubMed 26773557
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?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)
ClinicalTrials.gov ID: NCT01365507
Acronym / sponsor ID: BOOST™ / NN5401-3844
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 3 Jun 2011 (estimated)
Results: Posted 20 Nov 2015

Clinical summary

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

Study design

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

Arm	Type	Receives
IDegAsp Simple	Experimental	Drug: insulin degludec/insulin aspart
IDegAsp Step wise	Experimental	Drug: insulin degludec/insulin aspart

Who may qualify

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

Key inclusion criteria (6 listed)

Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
BMI (Body Mass Index) below or equal to 45 kg/m^2

Key exclusion criteria (6 listed)

Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
Known or suspected hypersensitivity to trial products or related products
The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)

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 aspartAlso: IDegAspInsulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.	Drug	IDegAsp Simple, IDegAsp Step wise

Primary outcome

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

4 secondary outcomes

Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Rate of Treatment Emergent Adverse Events (AEs)
Time frame: Week 0 to Week 26 + 7 days follow up
Rate of Confirmed Hypoglycaemic Episodes
Time frame: 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

Results and safety

Results posted to the registry on 20 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 Simple	136	127
IDegAsp Step Wise	140	131

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

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

Measure	IDegAsp Simple n = 136	IDegAsp Step Wise n = 140
Value	-1.33 (1.03)	-1.09 (0.82)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).

4 secondary outcomes are 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 Simple	1 of 134 (0.7%)	20 of 134 (14.9%)	Not reported
IDegAsp Step Wise	6 of 140 (4.3%)	26 of 140 (18.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26773557Park SW, Bebakar WM, Hernandez PG, Macura S, Herslov ML, de la Rosa R. Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST(R) : SIMPLE USE). Diabet Med. 2017 Feb;34(2):174-179. doi: 10.1111/dme.13069. Epub 2016 Mar 6.
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

42 sites in 7 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 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 42 sites in 7 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 6 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 17 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 42 sites in United States, South Korea, Turkey (Türkiye), Malaysia, Mexico and 2 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 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 NCT01365507, which also lists 2 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 17 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.