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Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes (SimpleMix™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01427920
First received: August 31, 2011
Last updated: October 16, 2014
Last verified: October 2014
Results First Received: July 3, 2013  
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: 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 33 sites in 5 countries enrolled subjects.

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
Subject-driven The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Investigator-driven The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.

Participant Flow:   Overall Study
    Subject-driven     Investigator-driven  
STARTED     174     174  
Exposed     174     173 [1]
COMPLETED     165     157  
NOT COMPLETED     9     17  
Adverse Event                 1                 2  
Lack of Efficacy                 1                 0  
Protocol Violation                 1                 3  
Withdrawal Criteria                 4                 4  
Unclassified                 2                 8  
[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
Subject-driven The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Investigator-driven The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
Total Total of all reporting groups

Baseline Measures
    Subject-driven     Investigator-driven     Total  
Number of Participants  
[units: participants]
  174     174     348  
Age  
[units: years]
Mean ± Standard Deviation
  58.9  ± 9.8     58.0  ± 9.5     58.5  ± 9.6  
Gender  
[units: participants]
     
Female     83     87     170  
Male     91     87     178  
Body Weight  
[units: kg]
Mean ± Standard Deviation
  81.0  ± 16.2     78.0  ± 15.0     79.5  ± 15.7  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  29.7  ± 4.8     29.2  ± 4.7     29.4  ± 4.7  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean ± Standard Deviation
  8.3  ± 0.9     8.3  ± 0.9     8.3  ± 0.9  
Fasting Plasma Glucose  
[units: mmol/L]
Mean ± Standard Deviation
  9.1  ± 2.7     8.8  ± 2.8     9.0  ± 2.7  



  Outcome Measures
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1.  Primary:   Change in HbA1c (Glycosylated Haemoglobin) - FAS   [ Time Frame: Week 0, week 20 ]

2.  Primary:   Change in HbA1c (Glycosylated Haemoglobin) - PP   [ Time Frame: Week 0, week 20 ]

3.  Secondary:   Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)   [ Time Frame: Week 0, week 20 ]

4.  Secondary:   Number of Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: Week 0 to week 20 ]

5.  Secondary:   Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score   [ Time Frame: Week 0 ]

6.  Secondary:   Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score   [ Time Frame: Week 4 ]

7.  Secondary:   Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score   [ Time Frame: Week 20 ]


  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


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01427920     History of Changes
Other Study ID Numbers: BIASP-3878, 2010-024303-27, U1111-1118-4096
Study First Received: August 31, 2011
Results First Received: July 3, 2013
Last Updated: October 16, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
China: Food and Drug Administration
India: Ministry of Health and Family Wellfare
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
United Kingdom: Medicines and Healthcare Products Regulatory Agency