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: 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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 47 sites in 10 countries: Algeria (4), Bulgaria (7), Croatia (5), Czech Republic (4), Germany (5), Poland (5), Romania (5), Slovakia (3), Turkey (2), and Ukraine (7).

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 one of the following OADs: insulin secretagogue (sulphonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, α-glucosidase inhibitors for at least 12 weeks prior to randomisation.

Reporting Groups
  Description
IDegAsp BID Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
BIAsp 30 BID Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.

Participant Flow:   Overall Study
    IDegAsp BID     BIAsp 30 BID  
STARTED     197     197  
Exposed     196 [1]   195 [2]
COMPLETED     187     184  
NOT COMPLETED     10     13  
Adverse Event                 2                 3  
Withdrawal Criteria                 3                 0  
Unclassified                 5                 10  
[1] One (1) subject was withdrawn prior to exposure due to “non fulfilment of inclusion criteria”
[2] Two (2) subjects were withdrawn prior to exposure due to "withdrawal of consent"



  Baseline Characteristics
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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.
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Reporting Groups
  Description
IDegAsp BID Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
BIAsp 30 BID Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
Total Total of all reporting groups

Baseline Measures
    IDegAsp BID     BIAsp 30 BID     Total  
Number of Participants  
[units: participants]
  197     197     394  
Age [1]
[units: years]
Mean (Standard Deviation)
  59.0  (9.5)     58.8  (8.4)     58.9  (8.9)  
Gender [2]
[units: participants]
     
Female     95     96     191  
Male     102     101     203  
Glycosylated Haemoglobin (HbA1c) [3]
[units: Percent¬†(%)¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  8.5  (0.8)     8.3  (0.7)     8.4  (0.8)  
Fasting plasma glucose (FPG) [4]
[units: mmol/L]
Mean (Standard Deviation)
  10.5  (2.4)     10.0  (2.3)     10.2  (2.3)  
Body Weight [5]
[units: kg]
Mean (Standard Deviation)
  88.0  (15.0)     88.5  (14.9)     88.2  (14.9)  
[1] Subjects aged ≥18 years were enrolled in this study.
[2] Male and female aged ≥18 years were enrolled in this study.
[3] Glycosylated haemoglobin (HbA1c) was measured at baseline.
[4] Fasting plasma glucose (FPG) was measured at baseline.
[5] Body weight was measured at baseline.



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

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

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Week 0, week 26 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01513590     History of Changes
Other Study ID Numbers: NN5401-3940
2011-001712-61 ( EudraCT Number )
U1111-1120-5633 ( Other Identifier: WHO )
Study First Received: January 16, 2012
Results First Received: October 19, 2015
Last Updated: October 19, 2015
Health Authority: Algeria: Ministry of Health
Bulgaria: Ministry of Health
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Turkey: Ministry of Health
Ukraine: Ministry of Health Ukraine