Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
Completed · Phase 3
Conditions studied: Type 2 Diabetes Mellitus
In brief
This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
Key facts
- Study ID
- NCT00032487
- Run by
- VA Office of Research and Development
- People needed
- 1791
- Starts
- 2000-12-01
- Expected to finish
- 2008-05-30
- Last updated by the study team
- 2017-03-30
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.
You may not qualify if…
- Angina pectoris, Canadian Class I-II,
- congestive heart failure, Class III-IV,
- stroke, incapacitating or in last 6 months,
- Myocardial infarction (MI) or invasive cardiovascular procedure within the past six months,
- ongoing diabetic gangrene,
- BMI > 40,
- hemoglobinopathy that interferes with A1c monitoring,
- serum creatinine > 1.6 mg/dL,
- fasting C-peptide < 0.21 pmol/ml,
- Alanine Amino Transaminase (ALT) > 3 times normal or serum bilirubin > 1.9 mg/dL,
- malignancy or noncardiac life-threatening diseases making life expectancy < 5 years,
- autonomic neuropathy,
- symptomatic pancreatic insufficiency (endocrine or exocrine),
- recurrent seizures within the past year,
- hypopituitarism,
- pregnancy, lactation, or planning a pregnancy,
- active psychosis or substance abuse,
- lack of access to a person who can assist or be called in an emergency,
- underlying conditions that in the site PI's judgment may prevent adherence to protocol,
- current participation in another clinical trial
Where it is running
- Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
- Southern Arizona VA Health Care System, Tucson — Tucson, Arizona, United States
- VA Central California Health Care System, Fresno — Fresno, California, United States
- VA Medical Center, Long Beach — Long Beach, California, United States
- VA San Diego Healthcare System, San Diego — San Diego, California, United States
- Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
- Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
- Richard Roudebush VA Medical Center, Indianapolis — Indianapolis, Indiana, United States
- VA Medical Center, Lexington — Lexington, Kentucky, United States
- VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
- VA Medical Center, Omaha — Omaha, Nebraska, United States
- VA New Jersey Health Care System, East Orange — East Orange, New Jersey, United States
- VA Pittsburgh Health Care System — Pittsburgh, Pennsylvania, United States
- Ralph H Johnson VA Medical Center, Charleston — Charleston, South Carolina, United States
- VA Medical Center — Nashville, Tennessee, United States
- Michael E. DeBakey VA Medical Center (152) — Houston, Texas, United States
- VA South Texas Health Care System, San Antonio — San Antonio, Texas, United States
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
- VA Medical Center, Salem VA — Salem, Virginia, United States
- VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States
- VA Medical Center, San Juan — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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