NCT01045447|CompletedPhase 3Results

Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

BOOST™

A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN5401-3593U1111-1111-72262008-005767-34

Study Type

interventional

Target

465

Locations

9 countries

Sites

Timeline

RegisteredJan 2010

StartedJan 2010

CompletionOct 2010

Brief Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

Trial Health

On Track

Trial Health Score

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

Enrollment

465

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

9 countries

65 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

9 months study duration

Study Start

First participant enrolled

January 1, 2010

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed

5.1 years until next milestone

Results Posted

Study results publicly available

November 18, 2015

Completed

Last Updated

March 20, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

January 8, 2010

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 (1)

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

Study Arms (2)

IDegAsp OD

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludec/insulin aspartDRUG

Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted.

IDegAsp OD

insulin glargineDRUG

Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

IGlar OD

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
Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn \[NPH\] insulin) once daily (OD), for at least 3 months
Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
BMI maximum 40.0 kg/m\^2

You may not qualify if:

Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior to visit 1
Current rosiglitazone users
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)
Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Contact the study team to confirm eligibility.