DiabetesPhase 3BOOST™NCT01272193

Comparison of NN5401 With Insulin Glargine in Insulin Naive 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 50 sites in Japan.

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 Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency. Read more about this study

Who is it for?: Ages 20 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: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 296 participants
Where: 50 sitesJapan
Study dates: Jan 2011to Sep 2011
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 20 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
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 35.0 kg/m^2
Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Who cannot join

Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
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

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

Japan50 sites

Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, 070 0002
Novo Nordisk Investigational Site
Chigasaki-shi, Kanagawa, 253 0052
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0027
Novo Nordisk Investigational Site
Ebina-shi, 243 0432
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, 815 8555
Novo Nordisk Investigational Site
Iruma-shi, Saitama, 358 0003
Novo Nordisk Investigational Site
Izumisano, 598 0048
Novo Nordisk Investigational Site
Kamakura-shi, 247 0056
Novo Nordisk Investigational Site
Kanagawa-shi, Yokohama, 221 0802
Novo Nordisk Investigational Site
Kashiwa-shi, Chiba, 277 0825
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, 582 0005
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, 125 0054
Novo Nordisk Investigational Site
Kawagoe-shi, Saitama, 350 0851
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, 800 0252
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, 963 8851
Novo Nordisk Investigational Site
Kumamoto-shi, Kumamoto, 861 8045
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, 862 0976
Novo Nordisk Investigational Site
Kurume-shi, Fukuoka, 830 8577
Novo Nordisk Investigational Site
Kurume-shi, Fukuoka, 839 0863
Novo Nordisk Investigational Site
Kyoto-shi, Kyoto, 615 8125
Novo Nordisk Investigational Site
Matsumoto-shi, Nagano, 399 0006
Novo Nordisk Investigational Site
Miyazaki, 880 0034
Novo Nordisk Investigational Site
Naha, 900 0032
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, 311 0113
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, 662 0971
Novo Nordisk Investigational Site
Obihiro-shi, Hokkaido, 080 0016
Novo Nordisk Investigational Site
Obihiro-shi, Hokkaido, 080 0848
Novo Nordisk Investigational Site
Ogawa, 355 0321
Novo Nordisk Investigational Site
Ōita, 870 0039
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, 831 0016
Novo Nordisk Investigational Site
Ota-ku, Tokyo, 144 0035
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, 060-0001
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 062 0007
Novo Nordisk Investigational Site
Sapporo, Hokkaido, 060 0033
Novo Nordisk Investigational Site
Sappro-shi, Hokkaido, 060 8648
Novo Nordisk Investigational Site
Sasebo-shi, Nagasaki, 857 1165
Novo Nordisk Investigational Site
Sendai, 980 0021
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, 329 0433
Novo Nordisk Investigational Site
Shizuoka, 424 0853
Novo Nordisk Investigational Site
Tagajō-shi, 985 0852
Novo Nordisk Investigational Site
Tagawa-shi, Fukuoka, 825 8567
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, 569 1096
Novo Nordisk Investigational Site
Tamana-shi, Kumamoto, 865 0064
Novo Nordisk Investigational Site
Tokyo, 167 0043
Novo Nordisk Investigational Site
Tsuchiura-shi, Ibaraki, 300 0832
Novo Nordisk Investigational Site
Urasoe-shi,, 901 2104
Novo Nordisk Investigational Site
Yokohama-shi, Kanagawa, 227 0054

Other trials in Japan

About this study

Official title: A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)

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
Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
insulin glargineDrug
Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

Study groups in NCT01272193
Study group	Role	What they receive
IDegAsp OD	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart; Drug: insulin glargine
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)
Observed change from baseline in HbA1c after 26 weeks of treatment
Measured: Week 0, Week 26

Secondary outcomes (5)

Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
Measured: 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
Observed 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
Observed 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. 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
Change in Body Weight
Observed 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.

Jan 2011Sep 2011

First posted7 Jan 2011 (estimated)
Study startJan 2011
Primary completionSep 2011
Study completionSep 2011

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: 296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272193
Sponsor's protocol ID: NN5401-3896
Other IDs: U1111-1118-0124, JapicCTI-111385
Acronym: BOOST™
Status last verified: Feb 2017
First submitted: 6 Jan 2011
Last updated: 17 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5.
PubMed 23557077
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 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)
ClinicalTrials.gov ID: NCT01272193
Acronym / sponsor ID: BOOST™ / NN5401-3896
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 296 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 7 Jan 2011 (estimated)
Results: Posted 23 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 OD	Experimental	Drug: insulin degludec/insulin aspart, Drug: insulin glargine
IGlar OD	Active comparator	Drug: insulin glargine

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 35.0 kg/m^2
Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Key exclusion criteria (3 listed)

Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
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

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 aspartInjected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).	Drug	IDegAsp OD
insulin glargineAdministered according to approved labelling either as monotherapy or combined with no more than 2 OADs.	Drug	IDegAsp OD, IGlar OD

Primary outcome

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

5 secondary outcomes

Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Time frame: 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
Change in Body Weight
Time frame: Week 0, Week 26

Results and safety

Results posted to the registry on 23 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	147	137
IGlar OD	149	137

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 = 147	IGlar OD n = 149
Value	-1.35 (0.86)	-1.22 (0.98)

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

5 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 OD	5 of 147 (3.4%)	37 of 147 (25.2%)	Not reported
IGlar OD	3 of 149 (2%)	47 of 149 (31.5%)	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 23557077Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5.
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

50 sites in 1 country: 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 50 sites in Japan.

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 3 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 50 sites in Japan. 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 23 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 NCT01272193, 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.