A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®: INTENSIFY BID)

Novo Nordisk A/S1 site in 1 country40 target enrollmentMarch 2013

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/insulin aspart insulin aspart insulin degludec

Drugsinsulin degludec/insulin aspart insulin degludec insulin aspart

Overview

Phase: Phase 3
Intervention: insulin degludec/insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 40
Locations: 1
Primary Endpoint: Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

March 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory

Exclusion Criteria

•Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
•Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
•Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females

Arms & Interventions

IDegAsp BID + IAsp OD

Intervention: insulin degludec/insulin aspart

IDegAsp BID + IAsp OD

Intervention: insulin aspart

IDeg OD + IAsp TID

Intervention: insulin degludec

IDeg OD + IAsp TID

Intervention: insulin aspart

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time Frame: Week 0, week 26

Change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcomes

Number of Treatment Emergent Hypoglycaemic Episodes(During 26 weeks of treatment)
Incidence of Treatment Emergent Adverse Events (TEAEs)(During 26 weeks of treatment)
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes(During 26 weeks of treatment)
Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)