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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01365507
First received: May 31, 2011
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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.

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: No masking
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG after 26 weeks of treatment.

  • 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.

  • 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.

  • 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.


Enrollment: 276
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp Simple Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Other Name: 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 Name: IDegAsp

  Eligibility

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 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
  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: NCT01365507

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
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
United States, Florida
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32209-6511
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32258
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33027
United States, Kentucky
Novo Nordisk Investigational Site
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
United States, Maryland
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
Novo Nordisk Investigational Site
North East, Maryland, United States, 21901
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48235
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48085-5524
United States, Minnesota
Novo Nordisk Investigational Site
Eagan, Minnesota, United States, 55123
United States, New York
Novo Nordisk Investigational Site
Smithtown, New York, United States, 11787
United States, North Carolina
Novo Nordisk Investigational Site
Asheboro, North Carolina, United States, 27203
United States, Texas
Novo Nordisk Investigational Site
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
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 08308
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 110-746
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 150-950
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 158-710
Novo Nordisk Investigational Site
Suwon, Korea, Republic of, 16247
Malaysia
Novo Nordisk Investigational Site
Johor Bahru, Malaysia, 80100
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Novo Nordisk Investigational Site
Selangor, Malaysia, 46150
Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Novo Nordisk Investigational Site
Monterrey, Mexico, 64460
Puerto Rico
Novo Nordisk Investigational Site
Bayamon, Puerto Rico, 00961
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Novo Nordisk Investigational Site
Nakhon Ratchasima, Thailand, 30000
Turkey
Novo Nordisk Investigational Site
Antalya, Turkey, 07058
Novo Nordisk Investigational Site
Istanbul, Turkey, 34096
Novo Nordisk Investigational Site
Istanbul, Turkey, 34718
Novo Nordisk Investigational Site
Istanbul, Turkey, 34890
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: NCT01365507     History of Changes
Other Study ID Numbers: NN5401-3844
U1111-1117-0558 ( Other Identifier: WHO )
Study First Received: May 31, 2011
Results First Received: October 19, 2015
Last Updated: February 9, 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

ClinicalTrials.gov processed this record on March 24, 2017