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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:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00537303
First received: September 28, 2007
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
Results First Received: July 16, 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: 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
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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  
Number of Participants  
[units: participants]
 		  146     150     296  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     117     122     239  
>=65 years     29     28     57  
Age  
[units: years]
Mean ± Standard Deviation 		  58.3  ± 8.29     58.3  ± 8.54     58.3  ± 8.40  
Gender  
[units: participants]
 		     
Female     70     67     137  
Male     76     83     159  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     26     34     60  
Not Hispanic or Latino     108     103     211  
Unknown or Not Reported     12     13     25  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     6     6     12  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     8     9     17  
White     120     122     242  
More than one race     0     0     0  
Unknown or Not Reported     12     13     25  
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
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1.  Primary:   Glycosylated Haemoglobin A1c (HbA1c)   [ Time Frame: week 36 ]
  Show Outcome Measure 1

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

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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided by Novo Nordisk

Publications automatically indexed to this study:


Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00537303     History of Changes
Other Study ID Numbers: NN304-1833, 2007-000123-18
Study First Received: September 28, 2007
Results First Received: July 16, 2010
Last Updated: September 22, 2011
Health Authority: Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency for Medicines
Sweden: Medical Products Agency
Serbia: Medicines and Medical Devices Agency of Serbia
United Kingdom: Medicines and Healthcare Products Regulatory
United States: Food and Drug Administration
Norway: Norwegian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Denmark: Danish Medicines Agency