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

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

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

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:

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.

Moritz T, Duckworth W, Abraira C. Veterans Affairs diabetes trial--corrections. N Engl J Med. 2009 Sep 3;361(10):1024-5. No abstract available.

Emanuele N, Moritz T, Klein R, Davis MD, Glander K, Khanna A, Thottapurathu L, Bahn G, Duckworth W, Abraira C; Veterans Affairs Diabetes Trial Study Group. Ethnicity, race, and clinically significant macular edema in the Veterans Affairs Diabetes Trial (VADT). Diabetes Res Clin Pract. 2009 Nov;86(2):104-10. Epub 2009 Aug 31.

Turnbull FM, Abraira C, Anderson RJ, Byington RP, Chalmers JP, Duckworth WC, Evans GW, Gerstein HC, Holman RR, Moritz TE, Neal BC, Ninomiya T, Patel AA, Paul SK, Travert F, Woodward M. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009 Nov;52(11):2288-98. Epub 2009 Aug 5.

Abraira C, Duckworth WC, Moritz T; VADT Group. Glycaemic separation and risk factor control in the Veterans Affairs Diabetes Trial: an interim report. Diabetes Obes Metab. 2009 Feb;11(2):150-6. Epub 2008 Jul 29.

Emanuele N, Klein R, Moritz T, Davis MD, Glander K, Anderson R, Reda D, Duckworth W, Abraira C; VADT Study Group. Comparison of dilated fundus examinations with seven-field stereo fundus photographs in the Veterans Affairs Diabetes Trial. J Diabetes Complications. 2009 Sep-Oct;23(5):323-9. Epub 2008 Apr 11.

Meyers CD, McCarren M, Wong ND, Abraira C, Duckworth WC, Kashyap ML; VADT Investigators. Baseline achievement of lipid goals and usage of lipid medications in patients with diabetes mellitus (from the Veterans Affairs Diabetes Trial). Am J Cardiol. 2006 Jul 1;98(1):63-5. Epub 2006 May 4.

Duckworth WC, McCarren M, Abraira C; VADT Investigators. Control of cardiovascular risk factors in the Veterans Affairs Diabetes Trial in advanced type 2 diabetes. Endocr Pract. 2006 Jan-Feb;12 Suppl 1:85-8. Review.

Kirkman MS, McCarren M, Shah J, Duckworth W, Abraira C; VADT Study Group. The association between metabolic control and prevalent macrovascular disease in Type 2 diabetes: the VA Cooperative Study in diabetes. J Diabetes Complications. 2006 Mar-Apr;20(2):75-80.

Emanuele N, Sacks J, Klein R, Reda D, Anderson R, Duckworth W, Abraira C; Veterans Affairs Diabetes Trial Group. Ethnicity, race, and baseline retinopathy correlates in the veterans affairs diabetes trial. Diabetes Care. 2005 Aug;28(8):1954-8.

Abraira C, Duckworth W, McCarren M, Emanuele N, Arca D, Reda D, Henderson W; VA Cooperative Study of Glycemic Control and Complications in Diabetes Mellitus Type 2. Design of the cooperative study on glycemic control and complications in diabetes mellitus type 2: Veterans Affairs Diabetes Trial. J Diabetes Complications. 2003 Nov-Dec;17(6):314-22.

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

Agrawal L, Azad N, Emanuele NV, Bahn GD, Kaufman DG, Moritz TE, Duckworth WC, Abraira C; Veterans Affairs Diabetes Trial (VADT) Study Group. Observation on renal outcomes in the Veterans Affairs Diabetes Trial. Diabetes Care. 2011 Sep;34(9):2090-4. Epub 2011 Jul 20.

Anderson RJ, Bahn GD, Moritz TE, Kaufman D, Abraira C, Duckworth W; VADT Study Group. Blood pressure and cardiovascular disease risk in the Veterans Affairs Diabetes Trial. Diabetes Care. 2011 Jan;34(1):34-8. Epub 2010 Nov 8.

Saremi A, Moritz TE, Anderson RJ, Abraira C, Duckworth WC, Reaven PD; Veterans Affairs Diabetes Trial (VADT). Rates and determinants of coronary and abdominal aortic artery calcium progression in the Veterans Affairs Diabetes Trial (VADT). Diabetes Care. 2010 Dec;33(12):2642-7. Epub 2010 Aug 31.

Meier M, Hummel M. Cardiovascular disease and intensive glucose control in type 2 diabetes mellitus: moving practice toward evidence-based strategies. Vasc Health Risk Manag. 2009;5:859-71. Epub 2009 Nov 2. Review.

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 February 12, 2012