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Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842361
First received: February 11, 2009
Last updated: November 20, 2015
Last verified: November 2015
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30

  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
A total of 8 sites in Japan

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
SIAC Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
Mix30 Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.

Participant Flow:   Overall Study
    SIAC     Mix30  
STARTED     33     33  
Exposed     33     32 [1]
COMPLETED     32     31  
NOT COMPLETED     1     2  
Protocol Violation                 1                 0  
Unclassified                 0                 2  
[1] One subject withdrew prior to exposure to trial drug



  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
SIAC Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
Mix30 Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
Total Total of all reporting groups

Baseline Measures
    SIAC     Mix30     Total  
Number of Participants  
[units: participants]
  33     32     65  
Age  
[units: years]
Mean (Standard Deviation)
  64.3  (8.4)     64.7  (11.2)     64.5  (9.8)  
Gender  
[units: participants]
     
Female     9     14     23  
Male     24     18     42  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  7.36  (0.86)     7.44  (0.84)     7.40  (0.84)  
Fasting plasma glucose (FPG)  
[units: mg/L]
Mean (Standard Deviation)
  144.6  (36.4)     140.8  (38.6)     142.7  (37.3)  
Body weight  
[units: kg]
Mean (Standard Deviation)
  61.22  (9.88)     57.32  (7.94)     59.30  (9.12)  



  Outcome Measures
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1.  Primary:   Rate of Major and Minor Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 6 + 5 days follow up ]

2.  Primary:   Rate of Nocturnal Major and Minor Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 6 + 5 days follow up ]

3.  Secondary:   Number of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 6 + 5 days follow up ]

4.  Secondary:   Change in Body Weight   [ Time Frame: Week 0, Week 6 ]

5.  Secondary:   Electrocardiogram (ECG) Worsening   [ Time Frame: Week 0, Week 6 ]

6.  Secondary:   Diastolic BP (Blood Pressure)   [ Time Frame: Week 0, Week 6 ]

7.  Secondary:   Systolic BP (Blood Pressure)   [ Time Frame: Week 0, Week 6. ]


  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: NCT00842361     History of Changes
Other Study ID Numbers: NN5401-3570
JapicCTI-090712 ( Registry Identifier: JAPIC )
Study First Received: February 11, 2009
Results First Received: October 19, 2015
Last Updated: November 20, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare