NCT02762578|CompletedPhase 3Results

Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes

BOOST

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes BOOST: INTENSIFY PREMIX/ALL 2

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN5401-35982011-000085-36U1111-1118-8578CTR20150689

Study Type

interventional

Target

543

Locations

1 country

Sites

Timeline

RegisteredMay 2016

StartedMay 2016

CompletionJun 2017

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

543

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started May 2016

Geographic Reach

1 country

42 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

May 3, 2016

Completed

Same day until next milestone

Study Start

First participant enrolled

May 3, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2017

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

December 7, 2018

Completed

Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

May 3, 2016

Results QC Date

May 9, 2018

Last Update Submit

March 19, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.
At 26 weeks

Secondary Outcomes (47)

Change From Baseline in FPG (Fasting Plasma Glucose)
At 26 weeks
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Weeks 0-26
Change From Baseline in Body Weight
Week 0, Week 26
Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%
At 26 weeks
+42 more secondary outcomes

Study Arms (2)

IDegAsp BID

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

BIAsp 30 BID

ACTIVE COMPARATOR

Drug: biphasic insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Twice daily subcutaneous (sc, under the skin) injection.

IDegAsp BID

biphasic insulin aspartDRUG

Twice daily subcutaneous (sc, under the skin) injection.

BIAsp 30 BID

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female at least 18 years of age
Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily (OD) or BID with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body mass index (BMI) equal or below 40.0 kg/m\^2

You may not qualify if:

Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine oxidase (MAO) inhibitors
Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial
Previous participation in this trial. Participation is defined as screened.
Known or suspected hypersensitivity to trial products or related products

Contact the study team to confirm eligibility.