NCT01272193|CompletedPhase 3Results

Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

BOOST™

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-3896U1111-1118-0124JapicCTI-111385

Study Type

interventional

Target

296

Locations

1 country

Sites

Timeline

RegisteredJan 2011

StartedJan 2011

CompletionSep 2011

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

296

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jan 2011

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

50 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

January 1, 2011

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

4.2 years until next milestone

Results Posted

Study results publicly available

November 23, 2015

Completed

Last Updated

March 17, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

January 6, 2011

Results QC Date

October 21, 2015

Last Update Submit

February 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Week 26
Rate of Treatment Emergent Adverse Events (AEs)
Week 0 to Week 26 + 7 days follow up
Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Change in Body Weight
Week 0, Week 26

Study Arms (2)

IDegAsp OD

EXPERIMENTAL

Drug: insulin degludec/insulin aspartDrug: insulin glargine

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

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).

IDegAsp OD

insulin glargineDRUG

Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

IDegAsp ODIGlar OD

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.