A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes BOOST: INTENSIFY PREMIX/ALL 2

Novo Nordisk A/S1 site in 1 country543 target enrollmentMay 3, 2016

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/insulin aspart biphasic insulin aspart

Drugsinsulin degludec/insulin aspart biphasic insulin aspart

Overview

Phase: Phase 3
Intervention: insulin degludec/insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 543
Locations: 1
Primary Endpoint: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.

Registry

clinicaltrials.gov

Start Date

May 3, 2016

End Date

June 19, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•Male or female at least 18 years of age
•Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
•Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily (OD) or BID with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation
•HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
•Body mass index (BMI) equal or below 40.0 kg/m\^2

Exclusion Criteria

•Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)
•Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine oxidase (MAO) inhibitors
•Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
•Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
•Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial
•Previous participation in this trial. Participation is defined as screened.
•Known or suspected hypersensitivity to trial products or related products

Arms & Interventions

IDegAsp BID

Intervention: insulin degludec/insulin aspart

BIAsp 30 BID

Intervention: biphasic insulin aspart

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)

Time Frame: At 26 weeks

Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.

Secondary Outcomes

Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes(At 26 weeks)
Change From Baseline in Body Weight(Week 0, Week 26)
Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%(At 26 weeks)
Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment(Week 26)
Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes(At week 26)
Incidence of Treatment Emergent Adverse Events (TEAEs)(Weeks 0-26)
9-point Profile (SMPG) After 26 Weeks of Treatment(At week 26)
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes(Weeks 0-26)
Change From Baseline in FPG (Fasting Plasma Glucose)(At 26 weeks)
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes(Weeks 0-26)
Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment(Week 26)
Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes(At week 26)
9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment(At week 26)
2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment(At week 26)
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period(From week 16 to end of treatment (week 26) + 1 week follow-up)
Change in Health Related Quality of Life Questionnaire (SF -36)(Week 0, week 26)
Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?)(week 26)
Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment(At week 26)
2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets(From randomization till achievement of titration target (up to week 26))
Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device])(At week 26)
Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?)(week 26)
Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment(At week 26)
Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?)(week 26)
Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?)(week 26)
Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?)(week 26)
Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?)(week 26)
Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?)(week 26)
Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?)(week 26)
Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?)(week 26)
Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?)(week 26)
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment(Week 0-26)
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period(From week 16 to end of treatment (week 26) + 1 week follow-up)
Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?)(week 26)
Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?)(week 26)
Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?)(week 26)
Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?)(week 26)
Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D])(Week 0, week 26)
Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale)(week 26)
Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?)(week 26)
Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?)(week 26)
Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?)(week 26)
Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?)(week 26)
Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?)(week 26)
Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?)(week 26)
Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?)(week 26)
Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?)(week 26)
Device Specific Questionnaires II (Would You Recommend the Pen?)(week 26)