A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01814137
First received: March 15, 2013
Last updated: November 13, 2015
Last verified: November 2015
Results First Received: October 14, 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: insulin degludec
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 20 sites in 4 countries as follows: Germany: 1 site; Malaysia: 2 sites; Turkey: 1 site; United States: 16 sites. The subjects in this trial were to continue from trial NN5401-3941 (NCT01680341).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who did not reach the HbA1c target < 7.0% on IDegAsp BID after 26 weeks of treatment in trial NN5401-3941 were enrolled in this trial.

Reporting Groups
  Description
IDegAsp BID + IAsp OD Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
IDeg OD + IAsp TID Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.

Participant Flow:   Overall Study
    IDegAsp BID + IAsp OD     IDeg OD + IAsp TID  
STARTED     20     20  
COMPLETED     15     15  
NOT COMPLETED     5     5  
Adverse Event                 0                 1  
Withdrawal by Subject                 2                 2  
Physician Decision                 1                 1  
Unclassified                 2                 1  



  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.
Full analysis set (FAS) included all randomised subjects.

Reporting Groups
  Description
IDegAsp BID + IAsp OD Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
IDeg OD + IAsp TID Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
Total Total of all reporting groups

Baseline Measures
    IDegAsp BID + IAsp OD     IDeg OD + IAsp TID     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Mean (Standard Deviation)
  58.0  (8.0)     56.9  (8.1)     57.5  (8.0)  
Gender  
[units: participants]
     
Female     5     9     14  
Male     15     11     26  
Glycosylated haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  7.9  (0.7)     7.7  (0.6)     7.8  (0.7)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  7.3  (3.5)     8.6  (2.8)     7.9  (3.2)  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Incidence of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: During 26 weeks of treatment ]

3.  Secondary:   Number of Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: During 26 weeks of treatment ]

4.  Secondary:   Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes   [ Time Frame: During 26 weeks of treatment ]

5.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ 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
Due to the highly selected trial population randomised in this trial (N=40), the results should be interpreted with caution.


  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: NCT01814137     History of Changes
Other Study ID Numbers: NN5401-4003
2012-003152-37 ( EudraCT Number )
U1111-1132-2674 ( Other Identifier: WHO )
Study First Received: March 15, 2013
Results First Received: October 14, 2015
Last Updated: November 13, 2015
Health Authority: Algeria: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: Ministry of Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration