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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00032487
Recruitment Status : Completed
First Posted : March 22, 2002
Results First Posted : February 12, 2014
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin Drug: Glimepiride Drug: Rosiglitazone Drug: Metformin Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1791 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #465 - Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
Actual Study Start Date : December 1, 2000
Primary Completion Date : May 30, 2008
Study Completion Date : May 30, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: 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
Other Name: 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 Name: 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
Other Name: Glumetza


Outcome Measures

Primary Outcome Measures :
  1. Primary Major Macrovascular Events [ Time Frame: Post baseline time to the first major macrovascular event up to 82 months ]
    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 :
  1. Secondary Endpoint [ Time Frame: Post baseline time to first event up to 82 months ]
    New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.


Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032487


  Show 21 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
National Eye Institute (NEI)
SmithKline Beecham
Investigators
Study Chair: Carlos Abraira, MD Miami VA Healthcare System, Miami, FL
Study Chair: William Duckworth, MD Phoenix VA Health Care System, Phoenix, AZ
More Information

Publications:

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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00032487     History of Changes
Other Study ID Numbers: 465
First Posted: March 22, 2002    Key Record Dates
Results First Posted: February 12, 2014
Last Update Posted: March 30, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
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
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors