Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01892020
First received: June 28, 2013
Last updated: June 16, 2015
Last verified: June 2015
Results First Received: May 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: biphasic insulin aspart 50
Drug: biphasic human insulin 50

  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
This trial was conducted in 14 sites in one country (China).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events following enrolment of subjects, and prior to randomization.

Reporting Groups
  Description
Group A (BIAsp 50 - BHI 50)

In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.

Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).

Group B (BHI 50 - BIAsp 50)

In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.

Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).


Participant Flow for 2 periods

Period 1:   Period 1
    Group A (BIAsp 50 - BHI 50)     Group B (BHI 50 - BIAsp 50)  
STARTED     81     80  
COMPLETED     78     74  
NOT COMPLETED     3     6  
Adverse Event                 1                 1  
Protocol Violation                 2                 4  
Unclassified                 0                 1  

Period 2:   Period 2
    Group A (BIAsp 50 - BHI 50)     Group B (BHI 50 - BIAsp 50)  
STARTED     78     74  
COMPLETED     77     74  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  



  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
All Subjects In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  161  
Age  
[units: years]
Mean (Standard Deviation)
  59.1  (8.5)  
Gender  
[units: participants]
 
Female     88  
Male     73  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test   [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

2.  Secondary:   ­1-hour PPG Increment Following a Standard Meal Test   [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

3.  Secondary:   ­IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test   [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

4.  Secondary:   2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile   [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

5.  Secondary:   The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile   [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

6.  Secondary:   Incidence of Hypoglycemic Episodes   [ Time Frame: During 4 weeks of treatment in each treatment sequence ]

7.  Secondary:   Incidence of AEs (Adverse Event)   [ Time Frame: During 4 weeks of treatment in each treatment sequence ]


  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: NCT01892020     History of Changes
Other Study ID Numbers: BIASP-4058, U1111-1137-2342
Study First Received: June 28, 2013
Results First Received: May 4, 2015
Last Updated: June 16, 2015
Health Authority: China: Food and Drug Administration