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A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01713530
First received: October 22, 2012
Last updated: November 17, 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
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 in 5 countries (48 sites): Algeria (4), Austria (6), France (8), Norway (6) and United States (24).

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 The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
IDeg OD+IAsp

The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.

The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.


Participant Flow:   Overall Study
    IDegAsp BID     IDeg OD+IAsp  
STARTED     138     136  
Exposed     136 [1]   135 [2]
COMPLETED     113     117  
NOT COMPLETED     25     19  
Adverse Event                 0                 5  
Withdrawal criteria                 21                 12  
Unclassified                 4                 2  
[1] One (1) subject was randomised in error and 1 subject withdrew consent
[2] One (1) subject was withdrawn by the investigator



  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.
The full analysis set (FAS) included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”.

Reporting Groups
  Description
IDegAsp BID The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
IDeg OD+IAsp

The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.

The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.

Total Total of all reporting groups

Baseline Measures
    IDegAsp BID     IDeg OD+IAsp     Total  
Number of Participants  
[units: participants]
  138     136     274  
Age  
[units: years]
Mean (Standard Deviation)
     
Age     59.6  (8.3)     59.6  (9.2)     59.6  (8.7)  
Gender  
[units: Subjects]
     
Female     65     50     115  
Male     73     86     159  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.3  (0.9)     8.3  (0.7)     8.3  (0.8)  
Fasting plasma glucose  
[units: mmol/L]
Mean (Standard Deviation)
  9.0  (3.0)     8.8  (2.9)     8.9  (3.0)  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, week 26 ]

3.  Secondary:   Number of Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: During Weeks 0-26 ]

4.  Secondary:   Number of Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: During Weeks 0-26 ]

5.  Secondary:   Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes   [ Time Frame: Weeks 0-26 ]

6.  Secondary:   Incidence of Treatment Emergent Adverse Events (TEAE)   [ Time Frame: Weeks 0-26 ]


  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
No text entered.


  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: NCT01713530     History of Changes
Other Study ID Numbers: NN5401-3996
2012-002346-20 ( EudraCT Number )
U1111-1130-7135 ( Other Identifier: WHO )
Study First Received: October 22, 2012
Results First Received: October 16, 2015
Last Updated: November 17, 2015
Health Authority: Algeria: Ministry of Health
Austria: Agency for Health and Food Safety
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
United States: Food and Drug Administration