Clinical trial NCT02762578: Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
timeFrame: At 26 weeks
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose)
timeFrame: At 26 weeks
measure: Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: Weeks 0-26
measure: Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
timeFrame: Weeks 0-26
measure: Change From Baseline in Body Weight
timeFrame: Week 0, Week 26
measure: Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%
timeFrame: At 26 weeks
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Weeks 0-26
measure: Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment
timeFrame: Week 26
measure: Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment
timeFrame: Week 26
measure: Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes
timeFrame: At week 26
measure: Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes
timeFrame: At 26 weeks
measure: Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes
timeFrame: At week 26
measure: 9-point Profile (SMPG) After 26 Weeks of Treatment
timeFrame: At week 26
measure: Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment
timeFrame: At week 26
measure: Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment
timeFrame: At week 26
measure: 9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
timeFrame: At week 26
measure: 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets
timeFrame: From randomization till achievement of titration target (up to week 26)
measure: 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
timeFrame: At week 26
measure: Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment
timeFrame: Week 0-26
measure: Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
timeFrame: From week 16 to end of treatment (week 26) + 1 week follow-up
measure: Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period
timeFrame: From week 16 to end of treatment (week 26) + 1 week follow-up
measure: Change in Health Related Quality of Life Questionnaire (SF -36)
timeFrame: Week 0, week 26
measure: Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D])
timeFrame: Week 0, week 26
measure: Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device])
timeFrame: At week 26
measure: Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?)
timeFrame: week 26
measure: Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?)
timeFrame: week 26
measure: Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?)
timeFrame: week 26
measure: Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?)
timeFrame: week 26
measure: Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?)
timeFrame: week 26
measure: Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?)
timeFrame: week 26
measure: Device Specific Questionnaires II (Would You Recommend the Pen?)
timeFrame: week 26
Other outcomes:
Locations:
city: Hefei
country: China
facility: Novo Nordisk Investigational Site
state: Anhui
city: Hefei
country: China
facility: Novo Nordisk Investigational Site
state: Anhui
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: ChongQing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Fuzhou
country: China
facility: Novo Nordisk Investigational Site
state: Fujian
city: Fuzhou
country: China
facility: Novo Nordisk Investigational Site
state: Fujian
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Nanning
country: China
facility: Novo Nordisk Investigational Site
state: Guangxi
city: Nanning
country: China
facility: Novo Nordisk Investigational Site
state: Guangxi
city: Cangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Hubei
city: Baotou
country: China
facility: Novo Nordisk Investigational Site
state: Inner Mongolia
city: Changzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Zhenjiang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Changchun
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Changchun
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Changchun
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Siping
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Jinan
country: China
facility: Novo Nordisk Investigational Site
state: Shandong
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Chengdu
country: China
facility: Novo Nordisk Investigational Site
state: Sichuan
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
state: Tianjin
city: Kunming
country: China
facility: Novo Nordisk Investigational Site
state: Yunnan
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Yang W, Ma J, Hong T, Liu M, Miao H, Peng Y, Wang C, Xu X, Yang T, Nielsen AM, Pan L, Liu W, Zhao W. Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial. Diabetes Obes Metab. 2019 Jul;21(7):1652-1660. doi: 10.1111/dom.13703. Epub 2019 Apr 4.
citation: Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.