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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01680341
First received: August 31, 2012
Last updated: June 19, 2014
Last verified: June 2014
  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: IDegAsp
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG). [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Subjects with HbA1c below 7.0% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HbA1c below 7.0% without confirmed hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0-28 ] [ Designated as safety issue: No ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: Weeks 0-27 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes [ Time Frame: Weeks 0-27 ] [ Designated as safety issue: No ]

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: IDegAsp
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.
Experimental: IDegAsp Step wise Drug: IDegAsp
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680341

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, United States, 85395
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States, 94904
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92111
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
United States, Florida
Novo Nordisk Clinical Trial Call Center
Bradenton, Florida, United States, 34208
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
Novo Nordisk Clinical Trial Call Center
St. Petersburg, Florida, United States, 33709
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Suwanee, Georgia, United States, 30024
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Crystal Lake, Illinois, United States, 60012
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Avon, Indiana, United States, 46123
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Slidell, Louisiana, United States, 70461-4231
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Waltham, Massachusetts, United States, 02453
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Buckley, Michigan, United States, 49620
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States, 12206
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Charleston, South Carolina, United States, 29407
Novo Nordisk Clinical Trial Call Center
Myrtle Beach, South Carolina, United States, 29572-4610
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75251
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States, 76104
United States, Washington
Novo Nordisk Clinical Trial Call Center
Olympia, Washington, United States, 98502
Novo Nordisk Clinical Trial Call Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Kenosha, Wisconsin, United States, 53142-7884
Algeria
Algiers, Algeria, 16000
Germany
St. Ingbert, Germany, 66386
Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Turkey
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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01680341     History of Changes
Other Study ID Numbers: NN5401-3941, 2012-000373-23, U1111-1127-4114
Study First Received: August 31, 2012
Last Updated: June 19, 2014
Health Authority: Algeria: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: Medical Research Ethics Committee
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin Aspart
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014