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

NCT00032487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1791

Last updated 2017-03-30

Study results available
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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.

Conditions

Interventions

DRUG

Insulin

Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs Arm 1 Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs, add one injection of insulin Arm 2

DRUG

Glimepiride

Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2

DRUG

Rosiglitazone

Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2

DRUG

Metformin

Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • SmithKline Beecham

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Carlos Abraira, MD · Miami VA Healthcare System, Miami, FL

  • William Duckworth, MD · Phoenix VA Health Care System, Phoenix, AZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-01
Primary Completion
2008-05-30
Completion
2008-05-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00032487 on ClinicalTrials.gov