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

• Status: Completed
• Trial end date: 2008-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: National Eye Institute (NEI); SmithKline Beecham
• Treatments: Glimepiride; Insulin; Insulin, Globin Zinc; Metformin; Rosiglitazone

Criteria

Inclusion Criteria:

• Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.

Exclusion Criteria:

• 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