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/S1 site in 1 country296 target enrollmentJanuary 2011

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/insulin aspart insulin glargine

Drugsinsulin degludec/insulin aspart insulin glargine

Overview

Phase: Phase 3
Intervention: insulin degludec/insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 296
Locations: 1
Primary Endpoint: Change in Glycosylated Haemoglobin (HbA1c)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

September 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

IDegAsp OD

Intervention: insulin degludec/insulin aspart

IDegAsp OD

Intervention: insulin glargine

IGlar OD

Intervention: insulin glargine

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time Frame: Week 0, Week 26

Observed change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcomes

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)