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

  Show 32 Study Locations
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014