Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01589653
First received: April 30, 2012
Last updated: June 29, 2016
Last verified: June 2016
Results First Received: June 29, 2016  
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
The trial was conducted at 18 sites in 5 countries as follows: Egypt: 4 sites, Indonesia: 2 sites, Morocco: 4 sites, Saudi Arabia: 4 sites, Vietnam: 4 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The subjects continued on their previous NPH insulin and OADs upto randomisation (visit 2). At randomisation, the subjects discontinued these treatments except metformin.

Reporting Groups
  Description
Subject-driven Titration The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
Investigator-driven Titration The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.

Participant Flow:   Overall Study
    Subject-driven Titration     Investigator-driven Titration  
STARTED     76     79  
Exposed     76     78  
COMPLETED     69     68  
NOT COMPLETED     7     11  
Protocol Violation                 3                 1  
Withdrawal criteria                 4                 7  
Unclassified                 0                 3  



  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.
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Reporting Groups
  Description
Subject-driven Titration The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
Investigator-driven Titration The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
Total Total of all reporting groups

Baseline Measures
    Subject-driven Titration     Investigator-driven Titration     Total  
Number of Participants  
[units: participants]
  76     79     155  
Age  
[units: years]
Mean (Standard Deviation)
  54.4  (10.22)     54.9  (9.77)     54.7  (9.96)  
Gender  
[units: participants]
     
Female     60     56     116  
Male     16     23     39  
HbA1c (%)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.5  (0.88)     8.7  (0.78)     8.6  (0.83)  
Fasting plasma glucose (mg/dL)  
[units: mg/dL]
Mean (Standard Deviation)
  156.8  (59.03)     148.5  (54.24)     152.6  (56.64)  



  Outcome Measures
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1.  Primary:   Change in HbA1c From Baseline   [ Time Frame: Week 0, week 20 ]

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

3.  Secondary:   Number of Hypoglycaemic Episodes During the Trial From Baseline   [ Time Frame: Week 20 ]

4.  Secondary:   Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)   [ Time Frame: Week 0, week 20 ]

5.  Secondary:   Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden   [ Time Frame: Week 0, 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
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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: NCT01589653     History of Changes
Other Study ID Numbers: BIASP-3968
U1111-1125-7572 ( Other Identifier: WHO )
Study First Received: April 30, 2012
Results First Received: June 29, 2016
Last Updated: June 29, 2016
Health Authority: Indonesia: National Agency of Drug and Food Control
Morocco: Ministry of Health
Saudi Arabia: Ministry of Health
Vietnam: Ministry of Health
Egypt: Ministry of Health and Population