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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003152-37-DE

Enrollment

Registered

2012-11-23

Start date

2013-02-08

Completion date

Unknown

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: IDegAsp 30 PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin Degludec CAS Number: 8444439-96-9 Concentration unit: µmole/ml micromole(s)/millilitre Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HbA1c = 7.0% measured after 26 weeks of treatment in NN5401-3941, by central laboratory analysis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) vs. basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c);Secondary Objective: The secondary objectives are to compare: - Safety of IDegAsp BID + IAsp OD vs. basal bolus with IDeg OD + IAsp TID - Efficacy in terms of other measures of glycaemic control;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment	—

Measure

Time frame

Main Objective: The primary objective is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) vs. basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c);Secondary Objective: The secondary objectives are to compare: - Safety of IDegAsp BID + IAsp OD vs. basal bolus with IDeg OD + IAsp TID - Efficacy in terms of other measures of glycaemic control;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment

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Secondary

Measure	Time frame
Secondary end point(s): Safety endpoints: 1. Incidence of treatment emergent adverse events (TEAEs) 2. Hypoglycaemia - Number of treatment emergent hypoglycaemic episodes both according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured plasma glucose (PG) < 3.1 mmol/L (< 56 mg/dL)) as well as to the American Diabetes Association (ADA) definition - Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes Efficacy endpoint: 3. Change from baseline in fasting plasma glucose (FPG) ;Timepoint(s) of evaluation of this end point: Safety endpoints: 1.-2. During 26 weeks of treatment Efficacy endpoints: 3. After 26 weeks of treatment	—

Measure

Time frame

Secondary end point(s): Safety endpoints: 1. Incidence of treatment emergent adverse events (TEAEs) 2. Hypoglycaemia - Number of treatment emergent hypoglycaemic episodes both according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured plasma glucose (PG) < 3.1 mmol/L (< 56 mg/dL)) as well as to the American Diabetes Association (ADA) definition - Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes Efficacy endpoint: 3. Change from baseline in fasting plasma glucose (FPG) ;Timepoint(s) of evaluation of this end point: Safety endpoints: 1.-2. During 26 weeks of treatment Efficacy endpoints: 3. After 26 weeks of treatment

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Countries

Algeria, Germany, Malaysia, Turkey, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026