Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes (3L)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00506662
First received: July 24, 2007
Last updated: June 26, 2012
Last verified: June 2012
Results First Received: October 19, 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 NPH

  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 57 centres in 2 countries: France (35) and United Kingdom (22)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects in the trial were patients with type 2 diabetes being treated with oral anti-diabetic drug (OAD) therapy(ies) for at least 3 months prior to the trial and considered to benefit from insulin treatment. The randomisation target for this trial was 286.

Reporting Groups
  Description
Insulin Detemir Individually adjusted dose of insulin detemir once daily
Insulin NPH Individually adjusted dose of insulin NPH once daily

Participant Flow:   Overall Study
    Insulin Detemir     Insulin NPH  
STARTED     38     48  
COMPLETED     21     20  
NOT COMPLETED     17     28  
Adverse Event                 0                 2  
Lack of Efficacy                 1                 0  
Protocol Violation                 2                 4  
Trial terminated                 10                 16  
Not recorded                 4                 6  



  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.
No text entered.

Reporting Groups
  Description
Insulin Detemir Individually adjusted dose of insulin detemir once daily
Insulin NPH Individually adjusted dose of insulin NPH once daily
Total Total of all reporting groups

Baseline Measures
    Insulin Detemir     Insulin NPH     Total  
Number of Participants  
[units: participants]
  38     48     86  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     38     48     86  
Age  
[units: years]
Mean ± Standard Deviation
  77.6  ± 5.5     76.1  ± 4.9     76.8  ± 5.2  
Gender  
[units: participants]
     
Female     21     19     40  
Male     17     29     46  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  29.1  ± 4.6     29.8  ± 5.5     29.5  ± 5.1  
Duration of diabetes [1]
[units: years]
Mean ± Standard Deviation
  13.3  ± 10.3     15.2  ± 9.4     14.6  ± 9.8  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage of total haemoglobin]
Mean ± Standard Deviation
  9.26  ± 0.87     9.12  ± 0.78     9.19  ± 0.82  
Weight  
[units: kg]
Mean ± Standard Deviation
  77.4  ± 15.9     80.4  ± 16.4     79.0  ± 16.2  
[1] Number of years since diagnosis



  Outcome Measures
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1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c) at Month 7   [ Time Frame: week 0, month 7 ]

2.  Secondary:   Change in Glycosylated Haemoglobin (HbA1c) at Month 4   [ Time Frame: week 0, month 4 ]

3.  Secondary:   Change in Mean Fasting Plasma Glucose (FPG) at Month 7   [ Time Frame: week 0, month 7 ]

4.  Secondary:   Change in Mean Fasting Plasma Glucose (FPG) at Month 4   [ Time Frame: week 0, month 4 ]

5.  Secondary:   Change in Mean Pre-lunch Plasma Glucose at Month 7   [ Time Frame: week 0, month 7 ]

6.  Secondary:   Change in Mean Pre-lunch Plasma Glucose at Month 4   [ Time Frame: week 0, month 4 ]

7.  Secondary:   Change in Mean Pre-dinner Plasma Glucose at Month 7   [ Time Frame: week 0, month 7 ]

8.  Secondary:   Change in Mean Pre-dinner Plasma Glucose at Month 4   [ Time Frame: week 0, month 4 ]

9.  Secondary:   Change in Body Weight at Month 7   [ Time Frame: week 0, month 7 ]

10.  Secondary:   Change in Body Weight at Month 4   [ Time Frame: week 0, month 4 ]

11.  Secondary:   Mean Number of Total Hypoglycaemic Episodes, Month 1   [ Time Frame: weeks -2-0, month 1 ]

12.  Secondary:   Mean Number of Total Hypoglycaemic Episodes, Months 2-4   [ Time Frame: weeks -2-0, months 2-4 ]

13.  Secondary:   Mean Number of Total Hypoglycaemic Episodes, Months 5-7   [ Time Frame: weeks -2-0, months 5-7 ]


  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
Trial terminated prematurely due to low recruitment, and thus it was not possible to assess efficacy in this trial due to the small number of patients in each treatment group.


  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


No publications provided


Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00506662     History of Changes
Other Study ID Numbers: NN304-1808, 2006-006589-41
Study First Received: July 24, 2007
Results First Received: October 19, 2010
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency