Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01680341
First received: August 31, 2012
Last updated: November 24, 2015
Last verified: November 2015
Results First Received: October 16, 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 in 43 sites in 5 countries: Algeria (3 sites), Germany (5 sites), Malaysia (3 sites), Turkey (3 sites), and United States (29 sites).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
While entering the treatment period the subjects discontinued insulin glargine (IGlar) and sulfonylurea (SU)/glinides (if administered) but continued treatment with up to 3 other oral antidiabetic drugs (OADs) as prescribed.

Reporting Groups
  Description
IDegAsp Simple Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
IDegAsp Step Wise IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).

Participant Flow:   Overall Study
    IDegAsp Simple     IDegAsp Step Wise  
STARTED     136     136  
Exposed     135 [1]   134 [2]
COMPLETED     115     119  
NOT COMPLETED     21     17  
Adverse Event                 3                 2  
Unclassified                 18                 15  
[1] One (1) subject withdrew consent prior to exposure to trial product.
[2] Two (2) subjects withdrew consent prior to exposure to trial product.



  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 Simple Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
IDegAsp Step Wise IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
Total Total of all reporting groups

Baseline Measures
    IDegAsp Simple     IDegAsp Step Wise     Total  
Number of Participants  
[units: participants]
  136     136     272  
Age  
[units: years]
Mean (Standard Deviation)
  58.8  (9.8)     59.1  (9.4)     58.9  (9.6)  
Gender  
[units: participants]
     
Female     60     53     113  
Male     76     83     159  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  8.2  (0.9)     8.2  (0.9)     8.2  (0.9)  
Fasting plasma glucose  
[units: mmol/L]
Mean (Standard Deviation)
  7.8  (2.3)     8.1  (3.0)     8.0  (2.6)  



  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:   Subjects With HbA1c Below 7.0%   [ Time Frame: Week 26 ]

4.  Secondary:   Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia   [ Time Frame: Week 26 ]

5.  Secondary:   Incidence of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Weeks 0-28 ]

6.  Secondary:   Number of Treatment Emergent Confirmed Hypoglycaemic Episodes   [ Time Frame: Weeks 0-27 ]

7.  Secondary:   Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period   [ Time Frame: From week 16 to end of trial including follow-up (week 27) ]

8.  Secondary:   Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes   [ Time Frame: Weeks 0-27 ]


  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: NCT01680341     History of Changes
Other Study ID Numbers: NN5401-3941
2012-000373-23 ( EudraCT Number )
U1111-1127-4114 ( Other Identifier: WHO )
Study First Received: August 31, 2012
Results First Received: October 16, 2015
Last Updated: November 24, 2015
Health Authority: Algeria: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: Medical Research Ethics Committee
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration