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

This study has been completed.
Sponsor:
Collaborators:
SmithKline Beecham
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032487
First received: March 21, 2002
Last updated: March 7, 2014
Last verified: March 2014
  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 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.


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:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Primary Major Macrovascular Events [ Time Frame: Post baseline time to the first major macrovascular event up to 82 months ] [ Designated as safety issue: No ]
    Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.


Secondary Outcome Measures:
  • Secondary Endpoint [ Time Frame: Post baseline time to first event up to 82 months ] [ Designated as safety issue: No ]
    New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.


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: 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
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
Other Names:
  • Lantus,
  • NovoLog (aspart),
  • Novopen,
  • NPH,
  • Novolin R,
  • Lente
Drug: Glimepiride
Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2
Other Name: Amaryl
Drug: Rosiglitazone
Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2
Other Name: Avandia
Drug: Metformin
Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm 2
Other Names:
  • Fortamet,
  • Glucophage,
  • Glucophage XR,
  • Riomet,
  • Glumetza
Experimental: 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
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
Other Names:
  • Lantus,
  • NovoLog (aspart),
  • Novopen,
  • NPH,
  • Novolin R,
  • Lente
Drug: Glimepiride
Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2
Other Name: Amaryl
Drug: Rosiglitazone
Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2
Other Name: Avandia
Drug: Metformin
Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm 2
Other Names:
  • Fortamet,
  • Glucophage,
  • Glucophage XR,
  • Riomet,
  • Glumetza

  Show Detailed Description

  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,
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032487

  Hide Study Locations
Locations
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Central California Health Care System, Fresno
Fresno, California, United States, 93703
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Florida
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
VA Medical Center, Salem VA
Salem, Virginia, United States, 24153
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Puerto Rico
VA Medical Center, San Juan
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
SmithKline Beecham
Investigators
Study Chair: Carlos Abraira, MD Miami VA Healthcare System, Miami, FL
Study Chair: William Duckworth, MD Carl T. Hayden VA Medical Center, Phoenix AZ
  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
Results First Received: September 10, 2013
Last Updated: March 7, 2014
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
Insulin, Globin Zinc
Glimepiride
Rosiglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 19, 2014