Comparison of the efficacy and safety of two different dose adjustment regimens for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine

A trial comparing the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine - BOOST®: SIMPLE vs. STEPWISE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000373-23-DE

Enrollment

270

Registered

2012-05-25

Start date

2012-08-02

Completion date

Unknown

Last updated

2014-03-24

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: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: IDegAsp 30 PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Concentration unit: µmole/ml micromole(s)/millilitre Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - Type 2 diabetes (diagnosed clinically) for = 24 weeks prior to Visit 2 (randomisation) - Currently treated with IGlar and up to 3 OADs (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor) - All antidiabetic treatments should have been ongoing for =12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time - HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis - Body mass index (BMI) = 40 kg/m^2 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: - Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation) - Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation) - Uncontrolled or untreated severe hypertension defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator - Life-threatening disease (e.g. cancer)

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm the efficacy of the insulin degludec/insulin aspart (IDegAsp) twice daily (BID) simple titration algorithm in controlling glycaemia with respect to change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of treatment.;Secondary Objective: - To compare the efficacy of the IDegAsp BID simple titration algorithm versus IDegAsp BID stepwise titration algorithm after 26 weeks of treatment in terms of other measurements of glycaemic control - To compare the safety of the IDegAsp BID simple titration algorithm versus IDegAsp BID stepwise titration algorithm after 26 weeks of treatment;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: To confirm the efficacy of the insulin degludec/insulin aspart (IDegAsp) twice daily (BID) simple titration algorithm in controlling glycaemia with respect to change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of treatment.;Secondary Objective: - To compare the efficacy of the IDegAsp BID simple titration algorithm versus IDegAsp BID stepwise titration algorithm after 26 weeks of treatment in terms of other measurements of glycaemic control - To compare the safety of the IDegAsp BID simple titration algorithm versus IDegAsp BID stepwise titration algorithm after 26 weeks of treatment;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): Key secondary efficacy endpoints: 1. Change from baseline in fasting plasma glucose (FPG) 2. Subjects achieving HbA1c targets: * Proportion of subjects with HbA1c< 7.0% * Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes during the last 12 weeks of treatment or within 7 days from last randomised treatment including only subjects exposed for at least 12 weeks 3. Self-measured plasma glucose measurements (SMPGs). The endpoints from the 8-point profiles (SMPG) include: * 8-point profile * Mean of the 8-point profile * Prandial plasma glucose (PG) increment from 8-point profile Key secondary safety endpoints 1. Incidence of treatment emergent adverse events (TEAEs) 2. Hypoglycaemia a) Number of treatment emergent confirmed hypoglycaemic episodes both according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured PG < 3.1 mmol/L (< 56 mg/dL)) as well as to The American Diabetes Association (ADA) definition = 3.9 mmol/L (= 70 mg/dL) b) Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period (from week 16 to end of trial including follow-up). The maintenance period has been defined for data collection purposes only c) Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes ;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints: 1-3: At end of treatment (visit 28/26 weeks of treatment) - Key secondary safety endpoints 1: During 28 weeks of trial 2: a) During 28 weeks of trial b) From week 16 to end of trial including follow-up c) During 28 weeks of trial	—

Measure

Time frame

Secondary end point(s): Key secondary efficacy endpoints: 1. Change from baseline in fasting plasma glucose (FPG) 2. Subjects achieving HbA1c targets: * Proportion of subjects with HbA1c< 7.0% * Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes during the last 12 weeks of treatment or within 7 days from last randomised treatment including only subjects exposed for at least 12 weeks 3. Self-measured plasma glucose measurements (SMPGs). The endpoints from the 8-point profiles (SMPG) include: * 8-point profile * Mean of the 8-point profile * Prandial plasma glucose (PG) increment from 8-point profile Key secondary safety endpoints 1. Incidence of treatment emergent adverse events (TEAEs) 2. Hypoglycaemia a) Number of treatment emergent confirmed hypoglycaemic episodes both according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured PG < 3.1 mmol/L (< 56 mg/dL)) as well as to The American Diabetes Association (ADA) definition = 3.9 mmol/L (= 70 mg/dL) b) Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period (from week 16 to end of trial including follow-up). The maintenance period has been defined for data collection purposes only c) Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes ;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints: 1-3: At end of treatment (visit 28/26 weeks of treatment) - Key secondary safety endpoints 1: During 28 weeks of trial 2: a) During 28 weeks of trial b) From week 16 to end of trial including follow-up c) During 28 weeks of trial

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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