NCT01680341|CompletedPhase 3Results

Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

BOOST®

A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN5401-39412012-000373-23U1111-1127-4114

Study Type

interventional

Target

272

Locations

5 countries

Sites

Timeline

RegisteredSep 2012

StartedAug 2012

CompletionAug 2013

Brief Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

Trial Health

On Track

Trial Health Score

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

Enrollment

272

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Aug 2012

Geographic Reach

5 countries

45 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

12 months study duration

First Submitted

Initial submission to the registry

August 31, 2012

Completed

Same day until next milestone

Study Start

First participant enrolled

August 31, 2012

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2013

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed

Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

August 31, 2012

Results QC Date

October 16, 2015

Last Update Submit

March 6, 2018

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 (7)

Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, Week 26
Subjects With HbA1c Below 7.0%
Week 26
Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia
Week 26
Incidence of Treatment Emergent Adverse Events (TEAEs)
Weeks 0-28
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Weeks 0-27
+2 more secondary outcomes

Study Arms (2)

IDegAsp Simple

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

IDegAsp Step wise

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.

Also known as: IDegAsp

IDegAsp Simple

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
Body mass index (BMI) below or equal to 40 kg/m\^2

You may not qualify if:

Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
Life-threatening disease (e.g. cancer)

Contact the study team to confirm eligibility.