A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)

November 30, 2018 updated by: Novo Nordisk A/S

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

424

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

  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • Japan
      • Chuo-ku,, Japan, 104 0061
        • Novo Nordisk Investigational Site
      • Imizu-shi, Japan, 939 0363
        • Novo Nordisk Investigational Site
      • Kamakura-shi, Japan, 247 0056
        • Novo Nordisk Investigational Site
      • Kashiwara-shi, Osaka, Japan, 582-0005
        • Novo Nordisk Investigational Site
      • Koriyama-shi, Fukushima, Japan, 963-8851
        • Novo Nordisk Investigational Site
      • Kumamoto-shi, Kumamoto, Japan, 862-0976
        • Novo Nordisk Investigational Site
      • Matsumoto-shi, Japan, 390 8510
        • Novo Nordisk Investigational Site
      • Naha-shi,, Japan, 900 0032
        • Novo Nordisk Investigational Site
      • Naka-shi, Ibaraki, Japan, 311-0113
        • Novo Nordisk Investigational Site
      • Oita-shi, Japan, 870 0039
        • Novo Nordisk Investigational Site
      • Oyama-shi, Tochigi, Japan, 323-0022
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060-0062
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 062-0007
        • Novo Nordisk Investigational Site
      • Takatsuki-shi, Osaka, Japan, 569-1096
        • Novo Nordisk Investigational Site
      • Urasoe-shi,, Japan, 901 2104
        • Novo Nordisk Investigational Site
      • Yokohama-shi, Kanagawa, Japan, 235-0045
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Ansan, Korea, Republic of, 152-703
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 705-717
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 705-718
        • Novo Nordisk Investigational Site
      • Guri, Korea, Republic of, 471-101
        • Novo Nordisk Investigational Site
      • Gyeonggi, Korea, Republic of, 480-717
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 400-103
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • Novo Nordisk Investigational Site
      • Jeollanamdo, Korea, Republic of, 501-717
        • Novo Nordisk Investigational Site
      • Pusan, Korea, Republic of, 602-739
        • Novo Nordisk Investigational Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 02841
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 02447
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 134-701
        • Novo Nordisk Investigational Site
      • Suwon, Korea, Republic of, 16499
        • Novo Nordisk Investigational Site
      • Wonju, Korea, Republic of, 220-701
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Georgetown, Penang, Malaysia, 10450
        • Novo Nordisk Investigational Site
      • Johor Bahru, Malaysia, 80100
        • Novo Nordisk Investigational Site
      • Klang, Selangor, Malaysia, 41200
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Kota Kinabalu, Malaysia, 88586
        • Novo Nordisk Investigational Site
      • Putrajaya, Malaysia, 62250
        • Novo Nordisk Investigational Site
      • Seremban, Malaysia, 70300
        • Novo Nordisk Investigational Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Novo Nordisk Investigational Site
      • Taichung, Taiwan, 404
        • Novo Nordisk Investigational Site
      • Tainan city, Taiwan, 710
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 100
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 112
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female at least 18 years of age (at least 20 years for Japan)
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body mass index (BMI) maximum 35.0 kg/m^2

Exclusion Criteria:

  • Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
  • Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1
  • 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
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

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 BID
Drug: insulin degludec/insulin aspart
Injected subcutaneously twice daily. Dose was individually adjusted.
Active Comparator: BIAsp 30 BID
Drug: biphasic insulin aspart 30
Injected subcutaneously twice daily. Dose was individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment
Time Frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Time Frame: Week 26
Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Week 26
Rate of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.
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
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring 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
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 (Actual)

February 1, 2010

Primary Completion (Actual)

December 23, 2010

Study Completion (Actual)

December 23, 2010

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

January 29, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3597
  • U1111-1111-7210 (Other Identifier: WHO)
  • 101040 (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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