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

This study has been completed.
Sponsor:
Collaborators:
National Eye Institute (NEI)
SmithKline Beecham
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00032487
First received: March 21, 2002
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   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
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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 ]

Measure Type Primary
Measure Title Primary Major Macrovascular Events
Measure Description Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.
Time Frame Post baseline time to the first major macrovascular event up to 82 months  

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 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

Measured Values
   Arm 1   Arm 2 
Participants Analyzed 
[Units: Participants]
 899   892 
Primary Major Macrovascular Events 
[Units: Participants]
 264   235 


Statistical Analysis 1 for Primary Major Macrovascular Events
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] Log Rank
P Value [4] <0.05
Cox Proportional Hazard [5] 0.79
95% Confidence Interval .79 to .99
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Secondary Endpoint
Measure Description New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.
Time Frame Post baseline time to first event up to 82 months  

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 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

Measured Values
   Arm 1   Arm 2 
Participants Analyzed 
[Units: Participants]
 899   892 
Secondary Endpoint 
[Units: Participants]
 283   312 

No statistical analysis provided for Secondary Endpoint




  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
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