Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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]
     
<=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
  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


  Other Adverse Events
  Hide Other Adverse Events

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.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Arm 1   Arm 2
Total, other (not including serious) adverse events     
# participants affected / at risk   730/899 (81.20%)   675/892 (75.67%) 
Blood and lymphatic system disorders     
Blood † 1     
# participants affected / at risk   67/899 (7.45%)   87/892 (9.75%) 
# events   67   87 
Cardiac disorders     
Cardiac Disorders † 1     
# participants affected / at risk   69/899 (7.68%)   62/892 (6.95%) 
# events   69   62 
Ear and labyrinth disorders     
Ear † 1     
# participants affected / at risk   61/899 (6.79%)   52/892 (5.83%) 
# events   61   52 
Eye disorders     
Eye Disorders † 1     
# participants affected / at risk   185/899 (20.58%)   183/892 (20.52%) 
# events   185   183 
Gastrointestinal disorders     
Gastrointestinal Disorders † 1     
# participants affected / at risk   288/899 (32.04%)   289/892 (32.40%) 
# events   288   289 
General disorders     
General Disorders † 1     
# participants affected / at risk   315/899 (35.04%)   290/892 (32.51%) 
# events   315   290 
Immune system disorders     
Immune † 1     
# participants affected / at risk   67/899 (7.45%)   58/892 (6.50%) 
# events   67   58 
Infections and infestations     
Infections † 1     
# participants affected / at risk   385/899 (42.83%)   354/892 (39.69%) 
# events   385   354 
Injury, poisoning and procedural complications     
Injury † 1     
# participants affected / at risk   235/899 (26.14%)   227/892 (25.45%) 
# events   235   227 
Investigations     
Investigations † 1     
# participants affected / at risk   167/899 (18.58%)   174/892 (19.51%) 
# events   167   174 
Metabolism and nutrition disorders     
Metabolism † 1     
# participants affected / at risk   115/899 (12.79%)   132/892 (14.80%) 
# events   115   132 
Musculoskeletal and connective tissue disorders     
Musculoskeletal † 1     
# participants affected / at risk   493/899 (54.84%)   480/892 (53.81%) 
# events   493   480 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms † 1     
# participants affected / at risk   78/899 (8.68%)   64/892 (7.17%) 
# events   78   64 
Nervous system disorders     
Nervous system † 1     
# participants affected / at risk   318/899 (35.37%)   283/892 (31.73%) 
# events   318   283 
Psychiatric disorders     
Psychiatric † 1     
# participants affected / at risk   175/899 (19.47%)   166/892 (18.61%) 
# events   175   166 
Renal and urinary disorders     
Renal † 1     
# participants affected / at risk   138/899 (15.35%)   158/892 (17.71%) 
# events   138   158 
Reproductive system and breast disorders     
Reproductive † 1     
# participants affected / at risk   82/899 (9.12%)   62/892 (6.95%) 
# events   82   62 
Respiratory, thoracic and mediastinal disorders     
Respiratory † 1     
# participants affected / at risk   227/899 (25.25%)   218/892 (24.44%) 
# events   227   218 
Skin and subcutaneous tissue disorders     
Skin † 1     
# participants affected / at risk   214/899 (23.80%)   206/892 (23.09%) 
# events   214   206 
Surgical and medical procedures     
Surgical † 1     
# participants affected / at risk   77/899 (8.57%)   89/892 (9.98%) 
# events   77   89 
Vascular disorders     
Vascular † 1     
# participants affected / at risk   115/899 (12.79%)   90/892 (10.09%) 
# events   115   90 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (6.1)



  Limitations and Caveats
  Hide 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
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