Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)

This study has been completed.
Sponsor:
Collaborators:
SmithKline Beecham
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032487
First received: March 21, 2002
Last updated: March 7, 2014
Last verified: March 2014
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin
Drug: Glimepiride
Drug: Rosiglitazone
Drug: Metformin

  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
Twenty Veterans Affairs Medical Centers (VAMCs) were selected to participate in this cooperative study. The recruitment period was from 12/01/00 to 05/31/03.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A patient had to meet all the screening criteria for eligibility and had to sign a consent form with blood samples and meet all entry criteria for pre-randomization testing. Once the patient was deemed appropriate for the study, Hines completed the randomization assignment.

Reporting Groups
  Description
Standard Glycemic Control Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
Intensive Glycemic Control Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1

Participant Flow:   Overall Study
    Standard Glycemic Control     Intensive Glycemic Control  
STARTED     899     892  
COMPLETED     760     772  
NOT COMPLETED     139     120  
Withdrawal by Subject                 67                 43  
Adverse Event                 3                 7  
Lost to Follow-up                 57                 58  
Had other reason                 12                 12  



  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
Arm 1/Standard Glycemic Control Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
Arm 2/Intensive Glycemic Control Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
Total Total of all reporting groups

Baseline Measures
    Arm 1/Standard Glycemic Control     Arm 2/Intensive Glycemic Control     Total  
Number of Participants  
[units: participants]
  899     892     1791  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     606     612     1218  
>=65 years     293     280     573  
Age  
[units: years]
Mean ± Standard Deviation
  60.3  ± 9.0     60.5  ± 9.0     60.4  ± 9.0  
Gender  
[units: participants]
     
Female     26     26     52  
Male     873     866     1739  
Region of Enrollment  
[units: participants]
     
United States     899     892     1791  



  Outcome Measures
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1.  Primary:   Primary Major Macrovascular Events   [ Time Frame: Post baseline time to the first major macrovascular event up to 82 months ]

2.  Secondary:   Secondary Endpoint   [ Time Frame: Post baseline time to first event up to 82 months ]


  Serious Adverse Events
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Time Frame The adverse events were collected in a 82-month period.
Additional Description Adverse events were reported by staff at visits or the patient between visits. Staff submitted an Adverse event report, using the FDA Form 3500, for each patient with a severe or unexpected reaction that may reasonably be treatment-related. Reports were screened by the research pharmacist and Study Co-Chairs.

Reporting Groups
  Description
Arm 1 Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
Arm 2 Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1

Serious Adverse Events
    Arm 1     Arm 2  
Total, serious adverse events      
# participants affected / at risk     144/899 (16.02%)     197/892 (22.09%)  
Blood and lymphatic system disorders      
Blood and lymphatic Disorders † 1    
# participants affected / at risk     12/899 (1.33%)     15/892 (1.68%)  
# events     12     15  
Cardiac disorders      
Cardiac disorders † 1    
# participants affected / at risk     36/899 (4.00%)     40/892 (4.48%)  
# events     36     40  
Congenital, familial and genetic disorders      
Congenital, familial and genetic Disorders † 1    
# participants affected / at risk     2/899 (0.22%)     4/892 (0.45%)  
# events     2     4  
Endocrine disorders      
Endocrine Disorders † 1    
# participants affected / at risk     2/899 (0.22%)     1/892 (0.11%)  
# events     2     1  
Eye disorders      
Eye Disorders † 1    
# participants affected / at risk     6/899 (0.67%)     2/892 (0.22%)  
# events     6     2  
Gastrointestinal disorders      
Gastrointestinal disorders † 1    
# participants affected / at risk     40/899 (4.45%)     37/892 (4.15%)  
# events     40     37  
General disorders      
General Disorders † 1    
# participants affected / at risk     32/899 (3.56%)     36/892 (4.04%)  
# events     32     36  
Hepatobiliary disorders      
Hepatobiliary Disorders † 1    
# participants affected / at risk     6/899 (0.67%)     9/892 (1.01%)  
# events     6     9  
Infections and infestations      
Infections and infestations † 1    
# participants affected / at risk     81/899 (9.01%)     71/892 (7.96%)  
# events     81     71  
Injury, poisoning and procedural complications      
Injury, poisoning and procedural complications † 1    
# participants affected / at risk     31/899 (3.45%)     26/892 (2.91%)  
# events     31     26  
Investigations      
Investigations † 1    
# participants affected / at risk     22/899 (2.45%)     22/892 (2.47%)  
# events     22     22  
Metabolism and nutrition disorders      
Metabolism and Nutrition Disorders † 1    
# participants affected / at risk     25/899 (2.78%)     27/892 (3.03%)  
# events     25     27  
Musculoskeletal and connective tissue disorders      
Musculoskeletal and connective tissue disorders † 1    
# participants affected / at risk     20/899 (2.22%)     38/892 (4.26%)  
# events     20     38  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Neoplasms benign, malignant and unspecified † 1    
# participants affected / at risk     25/899 (2.78%)     23/892 (2.58%)  
# events     25     23  
Nervous system disorders      
Nervous System Disorders † 1    
# participants affected / at risk     29/899 (3.23%)     36/892 (4.04%)  
# events     29     36  
Psychiatric disorders      
Psychiatric Disorders † 1    
# participants affected / at risk     14/899 (1.56%)     7/892 (0.78%)  
# events     14     7  
Renal and urinary disorders      
Renal and Urinary Disorders † 1    
# participants affected / at risk     25/899 (2.78%)     26/892 (2.91%)  
# events     25     26  
Reproductive system and breast disorders      
Reproductive system and brest Disorders † 1    
# participants affected / at risk     2/899 (0.22%)     6/892 (0.67%)  
# events     2     6  
Respiratory, thoracic and mediastinal disorders      
Respiratory, thoracic and mediastinal Disorders † 1    
# participants affected / at risk     25/899 (2.78%)     36/892 (4.04%)  
# events     25     36  
Skin and subcutaneous tissue disorders      
Skin and subcutaneous tissue Disorders † 1    
# participants affected / at risk     4/899 (0.44%)     12/892 (1.35%)  
# events     4     12  
Surgical and medical procedures      
Surgical and Medical Procedures † 1    
# participants affected / at risk     37/899 (4.12%)     33/892 (3.70%)  
# events     37     33  
Vascular disorders      
Vascular Disorders † 1    
# participants affected / at risk     22/899 (2.45%)     20/892 (2.24%)  
# events     22     20  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (6.1)




  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
Our study had several limitations. Since we were studying veterans, the patients were predominantly men, and extrapolation of our findings to women must be done with caution.Changes in therapeutic agents have occurred since the design of our protocol


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