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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®)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec/insulin aspart
insulin degludec
insulin aspart
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IDegAsp BID + IAsp OD

IDeg OD + IAsp TID

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcome Measures

Incidence of Treatment Emergent Adverse Events (TEAEs)
A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.
Number of Treatment Emergent Hypoglycaemic Episodes
Confirmed hypoglycaemic episodes were defined as episodes that are either: severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.

Full Information

First Posted
March 15, 2013
Last Updated
February 10, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01814137
Brief Title
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
Acronym
BOOST®
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDegAsp BID + IAsp OD
Arm Type
Experimental
Arm Title
IDeg OD + IAsp TID
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Description
Change from baseline in HbA1c after 26 weeks of treatment
Time Frame
Week 0, week 26
Secondary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Description
A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.
Time Frame
During 26 weeks of treatment
Title
Number of Treatment Emergent Hypoglycaemic Episodes
Description
Confirmed hypoglycaemic episodes were defined as episodes that are either: severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Time Frame
During 26 weeks of treatment
Title
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
Description
Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).
Time Frame
During 26 weeks of treatment
Title
Change From Baseline in Fasting Plasma Glucose (FPG)
Description
Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.
Time Frame
Week 0, week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Avon
State/Province
Illinois
ZIP/Postal Code
46123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461-4231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-8050
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Algiers
ZIP/Postal Code
16000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Tizi Ouzou
ZIP/Postal Code
16015
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Erdmannhausen
ZIP/Postal Code
71729
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Selangor
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Gaziantep
ZIP/Postal Code
27070
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Hatay
ZIP/Postal Code
31040
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27853981
Citation
Bebakar WM, Chaykin L, Herslov ML, Rasmussen S. Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal-Bolus): Exploratory Randomized Trial in Type 2 Diabetes. Diabetes Ther. 2017 Feb;8(1):197-205. doi: 10.1007/s13300-016-0213-8. Epub 2016 Nov 16.
Results Reference
result
PubMed Identifier
35044568
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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