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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
insulin degludec/insulin aspart
insulin glargine
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

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

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria:

  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
  • Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

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
  • 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

Active Comparator

Arm Label

IDegAsp OD

IGlar OD

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
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
Observed 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
Observed 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. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Change in Body Weight
Observed change from baseline in body weight after 26 weeks of treatment

Full Information

First Posted
January 6, 2011
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01272193
Brief Title
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Acronym
BOOST™
Official Title
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

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
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDegAsp OD
Arm Type
Experimental
Arm Title
IGlar OD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c)
Description
Observed change from baseline in HbA1c after 26 weeks of treatment
Time Frame
Week 0, Week 26
Secondary Outcome Measure Information:
Title
Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Description
Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
Time Frame
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
Observed 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
Observed 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. 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
Title
Change in Body Weight
Description
Observed change from baseline in body weight after 26 weeks of treatment
Time Frame
Week 0, Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) Exclusion Criteria: Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
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
Asahikawa-shi, Hokkaido
ZIP/Postal Code
070 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chigasaki-shi, Kanagawa
ZIP/Postal Code
253 0052
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ebina-shi
ZIP/Postal Code
243 0432
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
815 8555
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Iruma-shi, Saitama
ZIP/Postal Code
358 0003
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Izumisano-shi
ZIP/Postal Code
598 0048
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kamakura-shi
ZIP/Postal Code
247 0056
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kanagawa-shi, Yokohama
ZIP/Postal Code
221 0802
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashiwa-shi, Chiba
ZIP/Postal Code
277 0825
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashiwara-shi, Osaka
ZIP/Postal Code
582 0005
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Katsushika-ku, Tokyo
ZIP/Postal Code
125 0054
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kawagoe-shi, Saitama
ZIP/Postal Code
350 0851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kitakyushu-shi, Fukuoka
ZIP/Postal Code
800 0252
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi, Fukushima
ZIP/Postal Code
963 8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi, Kumamoto
ZIP/Postal Code
861 8045
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi,Kumamoto
ZIP/Postal Code
862 0976
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kurume-shi, Fukuoka
ZIP/Postal Code
830 8577
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kurume-shi, Fukuoka
ZIP/Postal Code
839 0863
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kyoto-shi, Kyoto
ZIP/Postal Code
615 8125
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Matsumoto-shi, Nagano
ZIP/Postal Code
399 0006
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
ZIP/Postal Code
880 0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Naha-shi,
ZIP/Postal Code
900 0032
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Naka-shi, Ibaraki
ZIP/Postal Code
311 0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nishinomiya-shi, Hygo
ZIP/Postal Code
662 0971
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Obihiro-shi, Hokkaido
ZIP/Postal Code
080 0016
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Obihiro-shi, Hokkaido
ZIP/Postal Code
080 0848
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ogawa-machi
ZIP/Postal Code
355 0321
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oita-shi
ZIP/Postal Code
870 0039
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Okawa-shi, Fukuoka
ZIP/Postal Code
831 0016
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ota-ku, Tokyo
ZIP/Postal Code
144 0035
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oyama-shi, Tochigi
ZIP/Postal Code
323 0022
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo, Hokkaido
ZIP/Postal Code
060 0033
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060 0062
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062 0007
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sappro-shi, Hokkaido
ZIP/Postal Code
060 8648
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sasebo-shi, Nagasaki
ZIP/Postal Code
857 1165
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sendai-shi
ZIP/Postal Code
980 0021
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shimotsuke-shi, Tochigi
ZIP/Postal Code
329 0433
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka-shi
ZIP/Postal Code
424 0853
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tagajo-shi
ZIP/Postal Code
985 0852
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tagawa-shi, Fukuoka
ZIP/Postal Code
825 8567
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Takatsuki-shi, Osaka
ZIP/Postal Code
569 1096
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tamana-shi, Kumamoto
ZIP/Postal Code
865 0064
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
167 0043
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tsuchiura-shi, Ibaraki
ZIP/Postal Code
300 0832
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Urasoe-shi,
ZIP/Postal Code
901 2104
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yokohama-shi, Kanagawa
ZIP/Postal Code
227 0054
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23557077
Citation
Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5.
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

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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

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