A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01513590
First received: January 16, 2012
Last updated: March 6, 2013
Last verified: February 2013

January 16, 2012
March 6, 2013
January 2012
November 2012   (final data collection date for primary outcome measure)
Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01513590 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent nocturnal (00:01-05:59 am) severe or minor hypoglycaemic episodes [ Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product ] [ Designated as safety issue: No ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Responder for HbA1c (below 7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment including only subjects exposed for at least 12 weeks [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent AEs (adverse events) [ Time Frame: Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)

This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec/insulin aspart
    Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued
  • Drug: biphasic insulin aspart 30
    Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued
  • Experimental: IDegAsp
    Intervention: Drug: insulin degludec/insulin aspart
  • Active Comparator: BIAsp 30
    Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
394
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks
  • Current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (OADs): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), - Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, - Alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
  • Insulin naïve subject; allowed is: Previous short term insulin treatment up to 14 days
  • Insulin naïve subject; allowed is: Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
  • HbA1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body mass index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 12 weeks prior to visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
  • Anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
  • Cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Bulgaria,   Croatia,   Czech Republic,   Germany,   Poland,   Romania,   Slovakia,   Turkey,   Ukraine
 
NCT01513590
NN5401-3940, 2011-001712-61, U1111-1120-5633
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Anne Juul Engstrøm Novo Nordisk A/S
Novo Nordisk A/S
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP