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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032487
First received: March 21, 2002
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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 25% 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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Insulin
Drug: Glimepiride
Drug: Rosiglitazone
Drug: Metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #465 - Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome is the occurrence of any one of the following: myocardial infarction, surgery for atherosclerotic disease, stroke, congestive heart failure, or amputation for ischemic gangrene. [ Time Frame: Time to first primary event (survival analysis). ] [ Designated as safety issue: No ]

Enrollment: 1791
Study Start Date: December 2000
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard glycemic control to maintain HbA1c between 8.0-9.0%.
 Drug: Insulin Drug: Glimepiride Drug: Rosiglitazone Drug: Metformin
Experimental: 2
Intensive glycemic control lower HbA1c below 7.0%.
 Drug: Insulin Drug: Glimepiride Drug: Rosiglitazone Drug: Metformin

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  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  • AMI 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,
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032487

  Show 21 Study Locations
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Study Chair: Carlos Abraira, MD VA Medical Center, Miami
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032487     History of Changes
Other Study ID Numbers: 465
Study First Received: March 21, 2002
Last Updated: February 7, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
DM
glycemic control
insulin
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Rosiglitazone
Insulin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013