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: June 28, 2012
Last verified: June 2012
  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) in combination with metformin.


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 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:
  • Percentage 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 FPG (fasting plasma glucose) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks -1-27 ] [ Designated as safety issue: No ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-27 ] [ Designated as safety issue: No ]

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: Titration algorithm A Drug: IDegAsp
IDegAsp injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Experimental: Titration algorithm B Drug: IDegAsp
IDegAsp injected subcutaneously (under the skin) once daily. Dose individually adjusted.

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365507

  Show 30 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anne Marie Valentin Jensen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01365507     History of Changes
Other Study ID Numbers: NN5401-3844, U1111-1117-0558, 2010-022306-40
Study First Received: May 31, 2011
Last Updated: June 28, 2012
Health Authority: Malaysia: Drug Control Authority (DCA)
Mexico: National Institute of Public Health, Health Secretariat
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Ministry of Public Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014