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A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01814137
First Posted: March 19, 2013
Last Update Posted: March 21, 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 globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/insulin aspart Drug: insulin degludec Drug: 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 Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®: INTENSIFY BID)

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:
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: During 26 weeks of treatment ]
    A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.

  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]

    Confirmed hypoglycaemic episodes were defined as episodes that are either:

    • severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or
    • biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.

  • Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]
    Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).

  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.


Enrollment: 40
Study Start Date: March 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp BID + IAsp OD Drug: insulin degludec/insulin aspart
For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
Drug: insulin aspart
For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.
Experimental: IDeg OD + IAsp TID Drug: insulin degludec
For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
Drug: insulin aspart
For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.

  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:

  • HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory

Exclusion Criteria:

  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
  • Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
  • Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
  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): NCT01814137


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85020
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
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
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
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Novo Nordisk Investigational Site
Selangor, Malaysia, 46150
Turkey
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:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01814137     History of Changes
Other Study ID Numbers: NN5401-4003
2012-003152-37 ( EudraCT Number )
U1111-1132-2674 ( Other Identifier: WHO )
First Submitted: March 15, 2013
First Posted: March 19, 2013
Results First Submitted: October 14, 2015
Results First Posted: November 13, 2015
Last Update Posted: March 21, 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 Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs