A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes (BOOST™)

March 13, 2019 updated by: Novo Nordisk A/S

A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)

This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

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

  • Algeria
      • Algiers, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Oran, Algeria, 31000
        • Novo Nordisk Investigational Site
      • Setif, Algeria, 19000
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Novo Nordisk Investigational Site
      • Lukovit, Bulgaria, 5770
        • Novo Nordisk Investigational Site
      • Plovdiv, Bulgaria, 4002
        • Novo Nordisk Investigational Site
      • Ruse, Bulgaria, 7000
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1233
        • Novo Nordisk Investigational Site
  • Croatia
      • Karlovac, Croatia, 47000
        • Novo Nordisk Investigational Site
      • Osijek, Croatia, 31 000
        • Novo Nordisk Investigational Site
      • Rijeka, Croatia, 51 000
        • Novo Nordisk Investigational Site
      • Zadar, Croatia, 23000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • Czechia
      • Brno, Czechia, 65691
        • Novo Nordisk Investigational Site
      • Hradec Kralove, Czechia, 50005
        • Novo Nordisk Investigational Site
      • Praha, Czechia, 128 08
        • Novo Nordisk Investigational Site
      • Praha 10, Czechia, 100 00
        • Novo Nordisk Investigational Site
  • Germany
      • Bochum, Germany, 44869
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Wangen, Germany, 88239
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-445
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-044
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-538
        • Novo Nordisk Investigational Site
      • Mazowieckie, Poland, 09-400
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 020614
        • Novo Nordisk Investigational Site
      • Buzau, Romania, 120203
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800578
        • Novo Nordisk Investigational Site
      • Sibiu, Romania, 550176
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 821 02
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 040 01
        • Novo Nordisk Investigational Site
  • Turkey
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34096
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey
        • Novo Nordisk Investigational Site
      • Kocaeli, Turkey, 41380
        • Novo Nordisk Investigational Site
  • Ukraine
      • Dnipro, Ukraine, 49023
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Lviv, Ukraine, 79010
        • Novo Nordisk Investigational Site
      • Poltava, Ukraine, 36003
        • Novo Nordisk Investigational Site
      • Poltava, Ukraine, 36011
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21010
        • Novo Nordisk Investigational Site
      • Zhytomyr, Ukraine, 10002
        • 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:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
  • Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
  • Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days
  • Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
  • HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
  • Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
  • Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial products or related products

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
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
Active Comparator: BIAsp 30 BID
Drug: insulin degludec/insulin aspart
Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
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
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.
Week 0, week 26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes
Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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 am.
Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. 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.
Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
Change from baseline in body weight after 26 weeks of treatment.
Week 0, week 26
Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks
Time Frame: Week 26
Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 26
Number of Treatment Emergent AEs (Adverse Events)
Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product
A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.
Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product

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)

January 16, 2012

Primary Completion (Actual)

November 19, 2012

Study Completion (Actual)

November 19, 2012

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3940
  • 2011-001712-61 (EudraCT Number)
  • U1111-1120-5633 (Other Identifier: WHO)

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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