A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01059812
First received: January 29, 2010
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
Interventions: Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30

  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 45 sites in 5 countries: Japan (16 sites), South Korea (16 sites), Hong Kong (1 site), Malaysia (8 sites) and Taiwan (4 sites).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IDegAsp BID Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
BIAsp 30 BID Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.

Participant Flow:   Overall Study
    IDegAsp BID     BIAsp 30 BID  
STARTED     282     142  
Exposed     279 [1]   141 [2]
COMPLETED     245     126  
NOT COMPLETED     37     16  
Adverse Event                 9                 5  
Lack of Efficacy                 2                 2  
Protocol Violation                 3                 1  
Withdrawal Criteria                 9                 4  
Unclassified                 14                 4  
[1] Three subjects withdrew prior to exposure to trial drug
[2] One subject withdrew prior to exposure to trial drug



  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.
Baseline characterises are presented for full analysis set (FAS), which included all randomized subjects. In exceptional cases subjects from the FAS were eliminated; 2 subjects in the IDegAsp group were excluded from the FAS because the subjects were randomized in error in spite of being screening failures.

Reporting Groups
  Description
IDegAsp BID Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
BIAsp 30 BID Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Total Total of all reporting groups

Baseline Measures
    IDegAsp BID     BIAsp 30 BID     Total  
Number of Participants  
[units: participants]
  280     142     422  
Age  
[units: years]
Mean (Standard Deviation)
  59.1  (10.2)     61.2  (9.5)     59.8  (10.0)  
Gender  
[units: participants]
     
Female     129     63     192  
Male     151     79     230  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.4  (0.8)     8.4  (0.9)     8.4  (0.8)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  7.9  (2.5)     7.9  (2.5)     7.9  (2.5)  
Body weight at randomisation  
[units: kg]
Mean (Standard Deviation)
  66.1  (11.2)     66.0  (11.2)     66.0  (11.2)  



  Outcome Measures
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1.  Primary:   Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment   [ Time Frame: Week 0, Week 26 ]

2.  Secondary:   Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26   [ Time Frame: Week 26 ]

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

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

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


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01059812     History of Changes
Other Study ID Numbers: NN5401-3597
U1111-1111-7210 ( Other Identifier: WHO )
101040 ( Registry Identifier: JAPIC )
Study First Received: January 29, 2010
Results First Received: October 19, 2015
Last Updated: October 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare
Malaysia: National Pharmaceutical Control Bureau
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Hong Kong: Department of Health