NCT01513590|CompletedPhase 3Results

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

BOOST™

A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-39402011-001712-61U1111-1120-5633

Study Type

interventional

Target

394

Locations

10 countries

Sites

Timeline

RegisteredJan 2012

StartedJan 2012

CompletionNov 2012

Brief Summary

This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

394

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2012

Shorter than P25 for phase_3 diabetes

Geographic Reach

10 countries

49 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

10 months study duration

First Submitted

Initial submission to the registry

January 16, 2012

Completed

Same day until next milestone

Study Start

First participant enrolled

January 16, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2012

Completed

3 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

January 16, 2012

Results QC Date

October 19, 2015

Last Update Submit

March 13, 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.
Week 0, week 26

Secondary Outcomes (6)

Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes
Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
Change From Baseline in Body Weight
Week 0, week 26
Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks
Week 26
+1 more secondary outcomes

Study Arms (2)

IDegAsp BID

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

BIAsp 30 BID

ACTIVE COMPARATOR

Drug: insulin degludec/insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.

BIAsp 30 BIDIDegAsp 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 procedure that would not have been performed during normal management of the subject)
Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days
Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
Body mass index (BMI) below or equal to 40.0 kg/m\^2

You may not qualify if:

Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening)
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) 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 trial physician's opinion could interfere with the results of the trial
Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
Known or suspected hypersensitivity to trial products or related products

Contact the study team to confirm eligibility.