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

February 9, 2017 updated by: Novo Nordisk A/S

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Asahikawa-shi, Hokkaido, Japan, 070 0002
        • Novo Nordisk Investigational Site
      • Chigasaki-shi, Kanagawa, Japan, 253 0052
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 103 0027
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 103 0002
        • Novo Nordisk Investigational Site
      • Ebina-shi, Japan, 243 0432
        • Novo Nordisk Investigational Site
      • Fukuoka-shi, Fukuoka, Japan, 815 8555
        • Novo Nordisk Investigational Site
      • Iruma-shi, Saitama, Japan, 358 0003
        • Novo Nordisk Investigational Site
      • Izumisano-shi, Japan, 598 0048
        • Novo Nordisk Investigational Site
      • Kamakura-shi, Japan, 247 0056
        • Novo Nordisk Investigational Site
      • Kanagawa-shi, Yokohama, Japan, 221 0802
        • Novo Nordisk Investigational Site
      • Kashiwa-shi, Chiba, Japan, 277 0825
        • Novo Nordisk Investigational Site
      • Kashiwara-shi, Osaka, Japan, 582 0005
        • Novo Nordisk Investigational Site
      • Katsushika-ku, Tokyo, Japan, 125 0054
        • Novo Nordisk Investigational Site
      • Kawagoe-shi, Saitama, Japan, 350 0851
        • Novo Nordisk Investigational Site
      • Kitakyushu-shi, Fukuoka, Japan, 800 0252
        • Novo Nordisk Investigational Site
      • Koriyama-shi, Fukushima, Japan, 963 8851
        • Novo Nordisk Investigational Site
      • Kumamoto-shi, Kumamoto, Japan, 861 8045
        • Novo Nordisk Investigational Site
      • Kumamoto-shi,Kumamoto, Japan, 862 0976
        • Novo Nordisk Investigational Site
      • Kurume-shi, Fukuoka, Japan, 839 0863
        • Novo Nordisk Investigational Site
      • Kurume-shi, Fukuoka, Japan, 830 8577
        • Novo Nordisk Investigational Site
      • Kyoto-shi, Kyoto, Japan, 615 8125
        • Novo Nordisk Investigational Site
      • Matsumoto-shi, Nagano, Japan, 399 0006
        • Novo Nordisk Investigational Site
      • Miyazaki-shi, Japan, 880 0034
        • Novo Nordisk Investigational Site
      • Naha-shi,, Japan, 900 0032
        • Novo Nordisk Investigational Site
      • Naka-shi, Ibaraki, Japan, 311 0113
        • Novo Nordisk Investigational Site
      • Nishinomiya-shi, Hygo, Japan, 662 0971
        • Novo Nordisk Investigational Site
      • Obihiro-shi, Hokkaido, Japan, 080 0016
        • Novo Nordisk Investigational Site
      • Obihiro-shi, Hokkaido, Japan, 080 0848
        • Novo Nordisk Investigational Site
      • Ogawa-machi, Japan, 355 0321
        • Novo Nordisk Investigational Site
      • Oita-shi, Japan, 870 0039
        • Novo Nordisk Investigational Site
      • Okawa-shi, Fukuoka, Japan, 831 0016
        • Novo Nordisk Investigational Site
      • Ota-ku, Tokyo, Japan, 144 0035
        • Novo Nordisk Investigational Site
      • Oyama-shi, Tochigi, Japan, 323 0022
        • Novo Nordisk Investigational Site
      • Sapporo, Hokkaido, Japan, 060 0033
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060 0062
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060-0001
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 062 0007
        • Novo Nordisk Investigational Site
      • Sappro-shi, Hokkaido, Japan, 060 8648
        • Novo Nordisk Investigational Site
      • Sasebo-shi, Nagasaki, Japan, 857 1165
        • Novo Nordisk Investigational Site
      • Sendai-shi, Japan, 980 0021
        • Novo Nordisk Investigational Site
      • Shimotsuke-shi, Tochigi, Japan, 329 0433
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Japan, 424 0853
        • Novo Nordisk Investigational Site
      • Tagajo-shi, Japan, 985 0852
        • Novo Nordisk Investigational Site
      • Tagawa-shi, Fukuoka, Japan, 825 8567
        • Novo Nordisk Investigational Site
      • Takatsuki-shi, Osaka, Japan, 569 1096
        • Novo Nordisk Investigational Site
      • Tamana-shi, Kumamoto, Japan, 865 0064
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 167 0043
        • Novo Nordisk Investigational Site
      • Tsuchiura-shi, Ibaraki, Japan, 300 0832
        • Novo Nordisk Investigational Site
      • Urasoe-shi,, Japan, 901 2104
        • Novo Nordisk Investigational Site
      • Yokohama-shi, Kanagawa, Japan, 227 0054
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDegAsp OD
Drug: insulin degludec/insulin aspart
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).
Drug: insulin glargine
Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
Active Comparator: IGlar OD
Drug: insulin glargine
Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Observed change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Treatment Emergent Adverse Events (AEs)
Time Frame: Week 0 to Week 26 + 7 days follow up
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.
Week 0 to Week 26 + 7 days follow up
Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Time Frame: Week 26
Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
Week 26
Rate of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
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.
Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
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.
Week 0 to Week 26 + 7 days follow up
Change in Body Weight
Time Frame: Week 0, Week 26
Observed change from baseline in body weight after 26 weeks of treatment
Week 0, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3896
  • U1111-1118-0124 (Other Identifier: WHO)
  • JapicCTI-111385 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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