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Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00978627
First received: September 16, 2009
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 1
Interventions: Drug: insulin degludec/insulin aspart
Drug: insulin detemir
Drug: 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 79 sites in 9 countries: Denmark (3 sites), Poland (6 sites), Romania (8 sites), France (3 sites), United Kingdom (8 sites), Russian Federation (11 sites), Israel (4 sites), Australia (7 sites), and United States (29 sites). Some sites did not enrol subjects in the extension period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The total duration of treatment was up to 52 weeks (26 weeks [main trial: NN5401-3594, NCT00978627] + 26 weeks [extension trial: NN5401-3645]), separated by 1 week of wash-out period; during which subjects were treated with Neutral Protamine Hagedorn (NPH) insulin twice daily (BID) in combination with insulin aspart.

Reporting Groups
  Description
IDegAsp OD Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
IDet Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Participant Flow for 2 periods

Period 1:   Main: Week 0 to 26 (NN5401-3594)
    IDegAsp OD     IDet  
STARTED     366     182  
Exposed     362 [1]   180 [2]
COMPLETED     320     156  
NOT COMPLETED     46     26  
Adverse Event                 4                 3  
Lack of Efficacy                 2                 0  
Protocol Violation                 8                 6  
Withdrawal criteria                 7                 5  
Unclassified                 25                 12  
[1] Four subjects withdrew prior to exposure to trial products
[2] Two subjects withdrew prior to exposure to trial products

Period 2:   Extension: Week 27 to 52 (NN5401-3645)
    IDegAsp OD     IDet  
STARTED     254 [1]   122 [2]
COMPLETED     233     113  
NOT COMPLETED     21     9  
Adverse Event                 3                 0  
Protocol Violation                 4                 1  
Withdrawal criteria                 2                 1  
Unclassified                 12                 7  
[1] Sixty six subjects from main trial did not continue into extension trial
[2] Thirty four subjects from main trial did not continue into extension trial



  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.
No text entered.

Reporting Groups
  Description
IDegAsp OD Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
IDet Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
Total Total of all reporting groups

Baseline Measures
    IDegAsp OD     IDet     Total  
Number of Participants  
[units: participants]
  366     182     548  
Age  
[units: years]
Mean (Standard Deviation)
  40.7  (12.8)     42.6  (13.8)     41.3  (13.2)  
Gender  
[units: participants]
     
Female     176     100     276  
Male     190     82     272  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.3  (0.8)     8.3  (0.7)     8.3  (0.8)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  10.3  (4.7)     11.0  (4.8)     10.5  (4.8)  



  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 53 + 7 days follow up ]

3.  Primary:   Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 53 + 7 days follow up ]

4.  Primary:   Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 53 + 7 days of follow up ]

5.  Secondary:   Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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

7.  Secondary:   Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 53 ]

8.  Secondary:   Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

9.  Secondary:   Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 53 ]


  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: NCT00978627     History of Changes
Obsolete Identifiers: NCT01087606
Other Study ID Numbers: NN5401-3594
2008-005769-71 ( EudraCT Number )
U1111-1111-8943 ( Other Identifier: WHO )
2009-013412-13 ( EudraCT Number )
U1111-1113-2475 ( Other Identifier: WHO )
Study First Received: September 16, 2009
Results First Received: October 19, 2015
Last Updated: October 19, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Poland: Ministry of Health
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency