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Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680341
First Posted: September 7, 2012
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.


Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment.


Secondary Outcome Measures:
  • 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

  • Subjects With HbA1c Below 7.0% [ Time Frame: Week 26 ]
    Number of subjects with HbA1c below 7% after 26 weeks of treatment.

  • Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia [ Time Frame: Week 26 ]
    Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.

  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-28 ]
    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.

  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-27 ]
    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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.

  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period [ Time Frame: From week 16 to end of trial including follow-up (week 27) ]
    Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and 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.

  • Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-27 ]
    Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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 am.


Enrollment: 272
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp Simple Drug: insulin degludec/insulin aspart
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
Other Name: IDegAsp
Experimental: IDegAsp Step wise Drug: insulin degludec/insulin aspart
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
Other Name: IDegAsp

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
  • Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
  • Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
  • Life-threatening disease (e.g. cancer)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680341


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Greenbrae, California, United States, 94904
Novo Nordisk Investigational Site
San Diego, California, United States, 92111
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States, 33709
United States, Georgia
Novo Nordisk Investigational Site
Suwanee, Georgia, United States, 30024
United States, Illinois
Novo Nordisk Investigational Site
Avon, Illinois, United States, 46123
Novo Nordisk Investigational Site
Crystal Lake, Illinois, United States, 60012
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Massachusetts
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Michigan
Novo Nordisk Investigational Site
Buckley, Michigan, United States, 49620
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29407
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76132
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Novo Nordisk Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Novo Nordisk Investigational Site
Kenosha, Wisconsin, United States, 53142
Algeria
Novo Nordisk Investigational Site
Algiers, Algeria, 16000
Novo Nordisk Investigational Site
Oran, Algeria, 31000
Novo Nordisk Investigational Site
Tizi Ouzou, Algeria, 16015
Germany
Novo Nordisk Investigational Site
Erdmannhausen, Germany, 71729
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Neuwied, Germany, 56564
Novo Nordisk Investigational Site
Pohlheim, Germany, 35415
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Malaysia
Novo Nordisk Investigational Site
Cheras, Malaysia, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Novo Nordisk Investigational Site
Selangor, Malaysia, 46150
Turkey
Novo Nordisk Investigational Site
Antalya, Turkey, 07050
Novo Nordisk Investigational Site
Denizli, Turkey, 20070
Novo Nordisk Investigational Site
Gaziantep, Turkey, 27070
Novo Nordisk Investigational Site
Hatay, Turkey, 31040
Novo Nordisk Investigational Site
Istanbul, Turkey, 34752
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01680341     History of Changes
Other Study ID Numbers: NN5401-3941
2012-000373-23 ( EudraCT Number )
U1111-1127-4114 ( Other Identifier: WHO )
First Submitted: August 31, 2012
First Posted: September 7, 2012
Results First Submitted: October 16, 2015
Results First Posted: November 17, 2015
Last Update Posted: March 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs