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Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01618214
First received: June 11, 2012
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: January 30, 2014  
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
Subjects were recruited from 23 sites in 1 country.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were randomised in a 1:1 manner to one of the 2 treatment groups.

Reporting Groups
  Description
Subject-driven Titration Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
Investigator-driven Titration Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.

Participant Flow:   Overall Study
    Subject-driven Titration     Investigator-driven Titration  
STARTED     172     172  
Exposed     172     172  
COMPLETED     162     159  
NOT COMPLETED     10     13  
Adverse Event                 3                 1  
Lack of Efficacy                 1                 1  
Protocol Violation                 1                 4  
Withdrawal Criteria                 1                 2  
Unclassified                 4                 5  



  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 Titration Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
Investigator-driven Titration Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
Total Total of all reporting groups

Baseline Measures
    Subject-driven Titration     Investigator-driven Titration     Total  
Number of Participants  
[units: participants]
  172     172     344  
Age  
[units: years]
Mean ± Standard Deviation
  54.8  ± 7.3     53.4  ± 7.5     54.1  ± 7.4  
Gender  
[units: participants]
     
Female     79     101     180  
Male     93     71     164  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     172     172     344  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Weight  
[units: kg]
Mean ± Standard Deviation
  70.3  ± 11.3     69.5  ± 11.6     69.9  ± 11.5  
Body mass index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  25.76  ± 3.26     25.47  ± 3.01     25.62  ± 3.14  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean ± Standard Deviation
  8.10  ± 0.64     8.14  ± 0.67     8.12  ± 0.65  
Fasting Plasma Glucose  
[units: mmol/L]
Mean ± Standard Deviation
  8.83  ± 2.36     9.07  ± 2.43     8.95  ± 2.40  



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

2.  Secondary:   Percentage of Subjects Achieving HbA1c Below 7.0%   [ Time Frame: After 20 weeks of treatment ]

3.  Secondary:   Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%   [ Time Frame: After 20 weeks of treatment ]

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

5.  Secondary:   Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)   [ Time Frame: Week 0 to week 20 (inclusive). ]


  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


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01618214     History of Changes
Other Study ID Numbers: BIASP-3984, U1111-1126-7610
Study First Received: June 11, 2012
Results First Received: January 30, 2014
Last Updated: April 7, 2014
Health Authority: China: Food and Drug Administration