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Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537303
First Posted: October 1, 2007
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
Results First Submitted: July 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin detemir
Drug: insulin aspart

  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 67 centres in 12 countries participated: Denmark (1), Finland (6), France (5), Netherlands (6), Norway (5), Russian Federation (4), Serbia (2), South Africa (3), Spain (5), Sweden (3), United Kingdom (7), United States of America (20)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were included in a 12-weeks forced titration period with insulin detemir as add-on to current oral anti-diabetic drug (OAD) treatment. Those subjects who did not meet the HbA1c target below 7% were then randomised to one of the two treatment regimens. Any use of sulphonylurea was discontinued at the time of randomisation.

Reporting Groups
  Description
Advanced Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Basic Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Participant Flow:   Overall Study
    Advanced   Basic
STARTED   146   150 
COMPLETED   120   125 
NOT COMPLETED   26   25 
Adverse Event                1                4 
Lack of Efficacy                6                7 
Protocol Violation                8                4 
Withdrawal criteria                3                3 
Unclassified                8                7 



  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
Advanced Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Basic Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Total Total of all reporting groups

Baseline Measures
   Advanced   Basic   Total 
Overall Participants Analyzed 
[Units: Participants]
 146   150   296 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      117  80.1%      122  81.3%      239  80.7% 
>=65 years      29  19.9%      28  18.7%      57  19.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (8.29)   58.3  (8.54)   58.3  (8.40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      70  47.9%      67  44.7%      137  46.3% 
Male      76  52.1%      83  55.3%      159  53.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      26  17.8%      34  22.7%      60  20.3% 
Not Hispanic or Latino      108  74.0%      103  68.7%      211  71.3% 
Unknown or Not Reported      12   8.2%      13   8.7%      25   8.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      6   4.1%      6   4.0%      12   4.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8   5.5%      9   6.0%      17   5.7% 
White      120  82.2%      122  81.3%      242  81.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      12   8.2%      13   8.7%      25   8.4% 
Height 
[Units: Meter]
Mean (Standard Deviation)
 1.68  (0.10)   1.67  (0.10)   1.68  (0.10) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 88.8  (15.8)   88.0  (16.3)   88.4  (16.0) 
BMI (Body Mass Index) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.26  (4.26)   31.38  (4.92)   31.32  (4.60) 
Stratification 
[Units: Participants]
     
Metformin alone   62   64   126 
Metformin + other OAD   84   86   170 
HbA1c (glycosylated haemoglobin A1c) 
[Units: Percentage (%) of total haemoglobin]
Mean (Standard Deviation)
 8.89  (1.16)   8.67  (0.97)   8.78  (1.07) 
Diabetes history [1] 
[Units: Years]
Mean (Standard Deviation)
 11.82  (5.99)   12.68  (6.68)   12.25  (6.35) 
[1] Number of years since diagnosis


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycosylated Haemoglobin A1c (HbA1c)   [ Time Frame: week 36 ]

2.  Primary:   Glycosylated Haemoglobin A1c (HbA1c)   [ Time Frame: week 36 ]

3.  Secondary:   Hypoglycaemic Episodes   [ Time Frame: Weeks 0-36 ]

4.  Secondary:   Biochemistry: Serum Alanine Aminotransferase   [ Time Frame: week 36 ]

5.  Secondary:   Haematology: Haemoglobin Measured in Blood   [ Time Frame: week 36 ]

6.  Secondary:   Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide   [ Time Frame: week 36 ]


  Serious Adverse Events


  Other Adverse Events


  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
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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


Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00537303     History of Changes
Other Study ID Numbers: NN304-1833
2007-000123-18 ( EudraCT Number )
First Submitted: September 28, 2007
First Posted: October 1, 2007
Results First Submitted: July 16, 2010
Results First Posted: August 13, 2010
Last Update Posted: March 10, 2017