NCT01365507|CompletedPhase 3Results

Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

BOOST™

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN5401-3844U1111-1117-0558

Study Type

interventional

Target

276

Locations

7 countries

Sites

Timeline

RegisteredJun 2011

StartedJun 2011

CompletionApr 2012

Brief Summary

This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.

Trial Health

On Track

Trial Health Score

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

Enrollment

276

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jun 2011

Shorter than P25 for phase_3 diabetes

Geographic Reach

7 countries

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

10 months study duration

First Submitted

Initial submission to the registry

May 31, 2011

Completed

1 day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed

3.6 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

March 17, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

May 31, 2011

Results QC Date

October 19, 2015

Last Update Submit

February 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, week 26

Secondary Outcomes (4)

Change in Fasting Plasma Glucose (FPG)
Week 0, 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

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

Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Also known as: IDegAsp

IDegAsp SimpleIDegAsp Step wise

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
BMI (Body Mass Index) below or equal to 45 kg/m\^2
Ability and willingness to adhere to the protocol including self measurement of plasma glucose

You may not qualify if:

Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
Known or suspected hypersensitivity to trial products or related products
The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits

Contact the study team to confirm eligibility.