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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00506662
First received: July 24, 2007
Last updated: May 11, 2016
Last verified: May 2016
Results First Received: October 19, 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 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 
Overall Participants Analyzed 
[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) 
[1] Number of years since diagnosis
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) 


  Outcome Measures
  Show All Outcome Measures

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



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00506662     History of Changes
Other Study ID Numbers: NN304-1808
2006-006589-41 ( EudraCT Number )
Study First Received: July 24, 2007
Results First Received: October 19, 2010
Last Updated: May 11, 2016