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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™)

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ClinicalTrials.gov Identifier: NCT01365507
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : November 20, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 31, 2011
First Posted Date  ICMJE June 3, 2011
Results First Submitted Date  ICMJE October 19, 2015
Results First Posted Date  ICMJE November 20, 2015
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ]
Change from baseline in HbA1c after 26 weeks of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
Percentage change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ]
Change History Complete list of historical versions of study NCT01365507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
  • Change from baseline in FPG (fasting plasma glucose) [ Time Frame: Week 0, week 26 ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks -1-27 ]
  • Number of severe and minor treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-27 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE Drug: insulin degludec/insulin aspart
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Other Name: IDegAsp
Study Arms  ICMJE
  • Experimental: IDegAsp Simple
    Intervention: Drug: insulin degludec/insulin aspart
  • Experimental: IDegAsp Step wise
    Intervention: Drug: insulin degludec/insulin aspart
Publications * Park SW, Bebakar WM, Hernandez PG, Macura S, Hersløv ML, de la Rosa R. Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST(®) : SIMPLE USE). Diabet Med. 2017 Feb;34(2):174-179. doi: 10.1111/dme.13069. Epub 2016 Mar 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2012)
276
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2011)
270
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Malaysia,   Mexico,   Puerto Rico,   Thailand,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01365507
Other Study ID Numbers  ICMJE NN5401-3844
U1111-1117-0558 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

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