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A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01868542
First received: May 30, 2013
Last updated: May 19, 2016
Last verified: May 2016
Results First Received: May 19, 2016  
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
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
The trial was conducted at 6 sites in 1 country: South Korea

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Insulin Detemir (3-0-3 Algorithm ) A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs.
Insulin Detemir (2-4-6-8 Algorithm ) A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs.

Participant Flow:   Overall Study
    Insulin Detemir (3-0-3 Algorithm )     Insulin Detemir (2-4-6-8 Algorithm )  
STARTED     23     23  
COMPLETED     23     21  
NOT COMPLETED     0     2  
Protocol Violation                 0                 1  
Unclassified                 0                 1  



  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.
Full analysis set (FAS) - included all randomised subjects.

Reporting Groups
  Description
Insulin Detemir (3-0-3 Algorithm ) A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs.
Insulin Detemir (2-4-6-8 Algorithm ) A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs.
Total Total of all reporting groups

Baseline Measures
    Insulin Detemir (3-0-3 Algorithm )     Insulin Detemir (2-4-6-8 Algorithm )     Total  
Number of Participants  
[units: participants]
  23     23     46  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     19     36  
>=65 years     6     4     10  
Gender  
[units: participants]
     
Female     14     11     25  
Male     9     12     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.   [ Time Frame: Week 0, week 20 ]

2.  Secondary:   Change in HbA1c   [ Time Frame: Week 0, week 12 ]

3.  Secondary:   Proportion of Subjects Achieving HbA1c Below 7.0%   [ Time Frame: Week 20 ]

4.  Secondary:   Change in Fasting Plasma Glucose From Baseline   [ Time Frame: week 0, week 12 ]

5.  Secondary:   Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.   [ Time Frame: At 20 weeks of treatment and over 24 hours ]

6.  Secondary:   Change in Fasting Plasma Glucose From Baseline   [ Time Frame: Week 0, week 20 ]

7.  Secondary:   Incidence of Adverse Events   [ Time Frame: Week 20 ]


  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



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01868542     History of Changes
Other Study ID Numbers: NN304-3994
U1111-1132-9267 ( Other Identifier: WHO )
Study First Received: May 30, 2013
Results First Received: May 19, 2016
Last Updated: May 19, 2016
Health Authority: South Korea: Ministry of Food and Drug Safety