Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: October 19, 2015
Last verified: October 2015
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Intervention: Drug: insulin degludec/insulin aspart

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted at 38 sites in 6 countries: Malaysia, Mexico, South Korea, Thailand, Turkey and the United States (U.S.).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects continued their metformin monotherapy or metformin in any combination with 1 or 2 additional oral antidiabetic drugs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV inhibitors, α-glucosidase inhibitors, thiazolidinediones, all with unchanged dosing for at least 12 weeks prior to randomisation.

Reporting Groups
  Description
IDegAsp Simple Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
IDegAsp Step Wise Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.

Participant Flow:   Overall Study
    IDegAsp Simple     IDegAsp Step Wise  
STARTED     136     140  
Exposed     134 [1]   140  
COMPLETED     127     131  
NOT COMPLETED     9     9  
Withdrawal Criteria                 8                 5  
Unclassified                 1                 4  
[1] Two subjects withdrew before exposure to trial drug



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IDegAsp Simple Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
IDegAsp Step Wise Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Total Total of all reporting groups

Baseline Measures
    IDegAsp Simple     IDegAsp Step Wise     Total  
Number of Participants  
[units: participants]
  136     140     276  
Age  
[units: years]
Mean (Standard Deviation)
  57.0  (9.4)     55.8  (9.7)     56.4  (9.5)  
Gender  
[units: participants]
     
Female     59     84     143  
Male     77     56     133  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.3  (0.8)     8.2  (0.8)     8.3  (0.8)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  8.9  (2.4)     9.0  (2.3)     8.9  (2.4)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 0, week 26 ]

2.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, week 26 ]

3.  Secondary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

4.  Secondary:   Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

5.  Secondary:   Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com



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: October 19, 2015
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