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Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00455858
First received: April 3, 2007
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
Results First Received: December 16, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Intervention: Drug: insulin detemir

  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 eight study sites in South Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).

Reporting Groups
  Description
Insulin Detemir Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.

Participant Flow:   Overall Study
    Insulin Detemir  
STARTED     87 [1]
COMPLETED     81  
NOT COMPLETED     6  
Lost to Follow-up                 2  
Protocol Violation                 1  
Lack of Efficacy                 1  
Well controlled FPG without insulin                 1  
Withdrawal                 1  
[1] Enrolled in study and exposed to study drug



  Baseline Characteristics
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Reporting Groups
  Description
Insulin Detemir Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.

Baseline Measures
    Insulin Detemir  
Number of Participants  
[units: participants]
 		  87  
Age  
[units: years]
Mean ± Standard Deviation 		  55.7  ± 9.5  
Gender  
[units: participants]
 		 
Female     51  
Male     36  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20   [ Time Frame: week 0, week 20 ]
  Show Outcome Measure 1

2.  Secondary:   Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12   [ Time Frame: week 0, week 12 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: week 0, week 12, week 20 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%   [ Time Frame: week 12, week 20 ]
  Show Outcome Measure 4

5.  Secondary:   Occurence of Hypoglycaemic Episodes   [ Time Frame: weeks 0-20 ]
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Measure Type Secondary
Measure Title Occurence of Hypoglycaemic Episodes
Measure Description Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.
Time Frame weeks 0-20  
Safety Issue Yes  

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.
For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.

Reporting Groups
  Description
Insulin Detemir Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.

Measured Values
    Insulin Detemir  
Number of Participants Analyzed  
[units: participants]
 		  81  
Occurence of Hypoglycaemic Episodes  
[units: episodes]
 		 
Occurence of hypoglycaemic episodes: Diurnal     92  
Occurence of hypoglycaemic episodes: Nocturnal     78  
Occurence of hypoglycaemic episodes: Total     170  

No statistical analysis provided for Occurence of Hypoglycaemic Episodes




  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


Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00455858     History of Changes
Other Study ID Numbers: NN304-1762
Study First Received: April 3, 2007
Results First Received: December 16, 2009
Last Updated: June 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)