Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032487

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Glimepiride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	CSP#465 - Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)

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
1: Active Comparator Standard glycemic control to maintain HbA1c between 8.0-9.0%.	Drug: Insulin Drug: Glimepiride Drug: Rosiglitazone Drug: Metformin
2: Experimental 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 indexed to this study:

Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan 8;360(2):129-39. Epub 2008 Dec 17.

Responsible Party:	Department of Veterans Affairs ( Abraira, Carlos - Study Chair )
Study ID Numbers:	465
Study First Received:	March 21, 2002
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00032487
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

Study placed in the following topic categories:

Glimepiride
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009