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

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

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 08308
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 158-710
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 150-950
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 110-746
        • Novo Nordisk Investigational Site
      • Suwon, Korea, Republic of, 16247
        • Novo Nordisk Investigational Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Selangor, Malaysia, 46150
        • Novo Nordisk Investigational Site
  • Mexico
      • Monterrey, Mexico, 64460
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
      • Nakhon Ratchasima, Thailand, 30000
        • Novo Nordisk Investigational Site
  • Turkey
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34096
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34718
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Concord, California, United States, 94520-1926
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32258
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32209-6511
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017-3464
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
      • North East, Maryland, United States, 21901
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48085-5524
        • Novo Nordisk Investigational Site
    • Minnesota
      • Eagan, Minnesota, United States, 55123
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77070
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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:

  • 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

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 Simple
Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Other Names:
  • IDegAsp
Experimental: IDegAsp Step wise
Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Other Names:
  • IDegAsp

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
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
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 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
Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment.
Week 0, week 26
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 26 + 7 days follow up
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.
Week 0 to Week 26 + 7 days follow up

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

June 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 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

  • NN5401-3844
  • U1111-1117-0558 (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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