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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00032487
First Posted: March 22, 2002
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Eye Institute (NEI)
SmithKline Beecham
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 899   892   1791 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      606  67.4%      612  68.6%      1218  68.0% 
>=65 years      293  32.6%      280  31.4%      573  32.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.3  (9.0)   60.5  (9.0)   60.4  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      26   2.9%      26   2.9%      52   2.9% 
Male      873  97.1%      866  97.1%      1739  97.1% 
Region of Enrollment 
[Units: Participants]
     
United States   899   892   1791 


  Outcome Measures
  Show All Outcome Measures

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


  More Information