Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™)
Status and phase
Completed
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: insulin degludec/insulin aspart
Drug: insulin glargine
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
296 patients
Sex
All
Ages
20+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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)
Exclusion criteria
- 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 design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
296 participants in 2 patient groups
IDegAsp OD
Experimental group
Treatment:
Drug: insulin degludec/insulin aspart
Drug: insulin glargine
IGlar OD
Active Comparator group
Treatment:
Drug: insulin glargine
Trial contacts and locations
50
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Data sourced from clinicaltrials.gov
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