NCT01009580|CompletedPhase 3Results

Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes

BOOST™

A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes in Inadequate Glycaemic Control on Once or Twice Daily Premixed or Self-mixed Insulin Regimen With or Without OADs (BOOST™: Intensify Premix 1)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-35922008-005768-15U1111-1111-8545

Study Type

interventional

Target

447

Locations

10 countries

Sites

Timeline

RegisteredNov 2009

StartedNov 2009

CompletionAug 2010

Brief Summary

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 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

447

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Nov 2009

Shorter than P25 for phase_3 diabetes

Geographic Reach

10 countries

53 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

November 5, 2009

Completed

Same day until next milestone

Study Start

First participant enrolled

November 5, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2010

Completed

5.2 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

November 5, 2009

Results QC Date

October 19, 2015

Last Update Submit

November 30, 2018

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 (3)

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Week 26
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 BID

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

BIAsp 30 BID

EXPERIMENTAL

Drug: biphasic insulin aspart 30

Interventions

insulin degludec/insulin aspartDRUG

Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

IDegAsp BID

biphasic insulin aspart 30DRUG

BIAsp 30 BID

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID), with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU), glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before Visit 1
HbA1c 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 rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
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
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer

Contact the study team to confirm eligibility.