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Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens (BOOST™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec/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:

  • Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
  • Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
  • Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
  • BMI (Body Mass Index) below or equal to 45 kg/m^2
  • Ability and willingness to adhere to the protocol including self measurement of plasma glucose

Exclusion Criteria:

  • Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
  • Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
  • Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  • The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
  • Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits

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
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IDegAsp Simple

IDegAsp Step wise

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment.
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.

Full Information

First Posted
May 31, 2011
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01365507
Brief Title
Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
Acronym
BOOST™
Official Title
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (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 in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.

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
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDegAsp Simple
Arm Type
Experimental
Arm Title
IDegAsp Step wise
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Other Intervention Name(s)
IDegAsp
Intervention Description
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c)
Description
Change from baseline in HbA1c after 26 weeks of treatment.
Time Frame
Week 0, week 26
Secondary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose (FPG)
Description
Change from baseline in FPG after 26 weeks of treatment.
Time Frame
Week 0, week 26
Title
Rate of Treatment Emergent Adverse Events (AEs)
Description
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Rate of Confirmed Hypoglycaemic Episodes
Description
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description
Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Time Frame
Week 0 to Week 26 + 7 days follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2) Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total) Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) BMI (Body Mass Index) below or equal to 45 kg/m^2 Ability and willingness to adhere to the protocol including self measurement of plasma glucose Exclusion Criteria: Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2) Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician) Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period Known or suspected hypersensitivity to trial products or related products The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2) Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
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
Concord
State/Province
California
ZIP/Postal Code
94520-1926
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
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
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209-6511
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017-3464
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
North East
State/Province
Maryland
ZIP/Postal Code
21901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085-5524
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
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
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
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
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Nakhon Ratchasima
ZIP/Postal Code
30000
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
26773557
Citation
Park SW, Bebakar WM, Hernandez PG, Macura S, Herslov ML, de la Rosa R. Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST(R) : SIMPLE USE). Diabet Med. 2017 Feb;34(2):174-179. doi: 10.1111/dme.13069. Epub 2016 Mar 6.
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

Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

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