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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272193
First received: January 6, 2011
Last updated: October 21, 2015
Last verified: October 2015
Results First Received: October 21, 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 glargine

  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 48 sites in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects continued on not more than 2 oral antidiabetic drugs (excluding sulphonylureas/dipeptyl peptidase-4 [DPP-4] inhibitors/glinides) at the pre-randomisation dose level and dosing frequency.

Reporting Groups
  Description
IDegAsp OD Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
IGlar OD Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.

Participant Flow:   Overall Study
    IDegAsp OD     IGlar OD  
STARTED     147     149  
COMPLETED     137     137  
NOT COMPLETED     10     12  
Adverse Event                 1                 1  
Lack of Efficacy                 0                 3  
Withdrawal Criteria                 1                 1  
Unclassified                 8                 7  



  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 once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
IGlar OD Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Total Total of all reporting groups

Baseline Measures
    IDegAsp OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  147     149     296  
Age  
[units: years]
Mean (Standard Deviation)
  60.0  (10.0)     61.0  (9.6)     60.5  (9.8)  
Gender  
[units: participants]
     
Female     57     50     107  
Male     90     99     189  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.3  (0.8)     8.5  (0.8)     8.4  (0.8)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.0  (1.6)     9.1  (1.9)     9.0  (1.7)  
Body weight  
[units: kg]
Mean (Standard Deviation)
  66.2  (13.4)     66.4  (13.3)     66.3  (13.4)  



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

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

3.  Secondary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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

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

6.  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



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272193     History of Changes
Other Study ID Numbers: NN5401-3896
U1111-1118-0124 ( Other Identifier: WHO )
JapicCTI-111385 ( Registry Identifier: JAPIC )
Study First Received: January 6, 2011
Results First Received: October 21, 2015
Last Updated: October 21, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare