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

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. Identifier: NCT00032487
Recruitment Status : Completed
First Posted : March 22, 2002
Results First Posted : February 12, 2014
Last Update Posted : March 30, 2017
National Eye Institute (NEI)
SmithKline Beecham
Information provided by (Responsible Party):
VA Office of Research and Development

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

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
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

  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

  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