Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control

This study has been terminated.
(Due to technical issues relating to the Electronic diary data.)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00283049
First received: January 26, 2006
Last updated: January 7, 2011
Last verified: January 2011
Results First Received: December 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Insulin Glargine
Drug: Insulin Glulisine

  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
No text entered.

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 Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU) Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)

Participant Flow:   Overall Study
    Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)     Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)     Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)  
STARTED     128 [1]   128 [2]   130 [2]
COMPLETED     70     83     76  
NOT COMPLETED     58     45     54  
Adverse Event                 6                 1                 4  
Protocol Violation                 3                 0                 3  
Death                 1                 1                 1  
Lack of Efficacy                 0                 1                 1  
Lost to Follow-up                 4                 2                 5  
Withdrawal by Subject                 26                 24                 19  
Discontinuation of Study                 18                 16                 20  
No longer requires study treatment                 0                 0                 1  
[1] 2 randomized patients did not receive study drug and were not included in the safety population
[2] 1 randomized patient did not receive study drug and was not included in the safety population



  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.
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Reporting Groups
  Description
SU + TZD + IG Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
MET + TZD + IG Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
MET+SU + IG Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
Total Total of all reporting groups

Baseline Measures
    SU + TZD + IG     MET + TZD + IG     MET+SU + IG     Total  
Number of Participants  
[units: participants]
  128     128     130     386  
Age  
[units: years]
Mean ± Standard Deviation
  56.1  ± 9.57     54.7  ± 10.14     54.6  ± 9.41     55.2  ± 9.71  
Gender  
[units: participants]
       
Female     51     54     52     157  
Male     77     74     78     229  
Region of Enrollment  
[units: participants]
       
USA     128     128     130     386  
Body Mass Index (BMI)  
[units: kg/m²]
Mean ± Standard Deviation
  33.2  ± 6.41     34.3  ± 6.57     34.5  ± 7.04     34.0  ± 6.69  
Duration of diabetes  
[units: years]
Mean ± Standard Deviation
  10.5  ± 6.95     9.7  ± 5.68     10.5  ± 6.00     10.2  ± 6.23  
Weight  
[units: kg]
Mean ± Standard Deviation
  98.1  ± 21.46     99.6  ± 20.22     101.2  ± 24.98     99.6  ± 22.31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12   [ Time Frame: 12 weeks from Baseline ]

2.  Secondary:   Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage   [ Time Frame: 60 weeks from Baseline ]

3.  Secondary:   Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%   [ Time Frame: 60 weeks from Baseline ]

4.  Secondary:   Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)   [ Time Frame: 60 weeks from Baseline ]

5.  Secondary:   Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)   [ Time Frame: 60 weeks from Baseline ]

6.  Secondary:   Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia   [ Time Frame: 60 weeks from Baseline ]

7.  Secondary:   Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia   [ Time Frame: 60 Weeks from Baseline ]


  Serious Adverse Events


  Other Adverse Events


  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
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.  


Results Point of Contact:  
Name/Title: Medical Affairs study director
Organization: sanofi-aventis
e-mail: publicregistryUSMA@sanofi-aventis.com


No publications provided


Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00283049     History of Changes
Other Study ID Numbers: HOE901_4052
Study First Received: January 26, 2006
Results First Received: December 16, 2009
Last Updated: January 7, 2011
Health Authority: United States: Institutional Review Board