Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00807092
First received: December 10, 2008
Last updated: June 15, 2012
Last verified: April 2012
Results First Received: November 12, 2010  
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
Interventions: Drug: biphasic insulin aspart 30
Drug: biphasic human insulin 30
Drug: metformin

  Participant Flow
  Hide Participant Flow

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 10 sites across China

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All eligible subjects had their baseline blood glucose profiles monitored by continuous glucose monitoring system (CGMS) for 72 hours. Following CGMS uninstall and discontinuation of all previous oral anti-diabetic drug (OAD) treatment, subjects were randomised to one of two treatment groups.

Reporting Groups
  Description
BIAsp 30 BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
BHI 30 BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.

Participant Flow:   Overall Study
    BIAsp 30     BHI 30  
STARTED     72     73  
Exposed to Drug     71 [1]   73  
COMPLETED     71     69  
NOT COMPLETED     1     4  
Adverse Event                 0                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 1                 0  
CGMS data collection failed                 0                 1  
[1] Subject was randomised, but not exposed to any trial drug



  Baseline Characteristics
  Hide Baseline Characteristics

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
BIAsp 30 BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
BHI 30 BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
Total Total of all reporting groups

Baseline Measures
    BIAsp 30     BHI 30     Total  
Number of Participants  
[units: participants]
  71     73     144  
Age  
[units: years]
Mean ± Standard Deviation
  56.5  ± 9     54.4  ± 10.4     55.5  ± 9.8  
Gender  
[units: participants]
     
Female     33     39     72  
Male     38     34     72  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     71     73     144  
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
  66.28  ± 12     65.49  ± 11.4     65.88  ± 11.7  
Height at screening  
[units: m]
Mean ± Standard Deviation
  1.634  ± 0.09     1.623  ± 0.09     1.628  ± 0.09  
BMI (Body Mass Index)  
[units: kg/m^2]
Mean ± Standard Deviation
  24.68  ± 3     24.74  ± 3     24.71  ± 3  
Duration of diagnosed diabetes  
[units: years]
Mean ± Standard Deviation
  7.74  ± 5.5     7  ± 5.2     7.36  ± 5.3  
HbA1c at screening  
[units: percentage of total haemoglobin]
Mean ± Standard Deviation
  9.19  ± 1.05     9.08  ± 1.08     9.13  ± 1.06  
Metformin monotherapy or combination therapy at randomisation [1]
[units: participants]
     
Metformin Monotherapy     20     18     38  
Metformin Combination Therapy     51     55     106  
[1] OAD treatment at randomisation



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals   [ Time Frame: Week 0, week 6 ]

2.  Secondary:   Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS   [ Time Frame: Week 0, Week 6 ]

3.  Secondary:   Mean FBG (Fasting Blood Glucose) Assessed by CGMS   [ Time Frame: Week 6 ]

4.  Secondary:   Change in Mean FBG Assessed by CGMS   [ Time Frame: Week 0, week 6 ]

5.  Secondary:   Change in FPG (Fasting Plasma Glucose)   [ Time Frame: Week 0, Week 6 ]

6.  Secondary:   Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles   [ Time Frame: Week 0, Week 6 ]

7.  Secondary:   Change in Prandial Blood Glucose Increment   [ Time Frame: Week 0, Week 6 ]

8.  Secondary:   Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS   [ Time Frame: Week 0, Week 6 ]

9.  Secondary:   Change in GA (Glycated Albumin)   [ Time Frame: Week -2, week 6 ]

10.  Secondary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week -2, week 6 ]

11.  Secondary:   Duration of Hypoglycaemic Events Based on CGMS   [ Time Frame: 72-hour monitoring period at Week 0 and Week 6 ]

12.  Secondary:   Hypoglycaemia Based on Self-reported Episodes   [ Time Frame: Weeks 0-6 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame The adverse events were collected in a time span of 6 weeks (starting from the start of treatment to the end of treatment plus one day)
Additional Description The safety analysis set contains all randomised subjects exposed to at least one dose of trial drug(s).

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
BIAsp 30 BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
BHI 30 BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.

Other Adverse Events
    BIAsp 30     BHI 30  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/71     0/73  



  Limitations and Caveats
  Hide Limitations and Caveats

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