SOLICITATION NOTICE
B -- Research Clinical Trials
- Notice Date
- 12/22/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 263-2007-Q-DT-0066
- Response Due
- 1/11/2007
- Archive Date
- 1/26/2007
- Description
- The National Eye Institute is a component of the National Institutes of Health and has the following requirement: VA Diabetes Trial, CSP #465 ?Glycemic Control and Complications in Diabetes Mellitus Type 2? This study is designed to evaluate the following research question: Does intensive glucose control affect major macrovascular endpoints in a defined veteran population? This is a clinical trial designed and conducted with the expertise of the VA Cooperative Studies Program. The target populations will be patients with type 2 DM, over 40 years of age, with HbA1c greater than 4 SD above normal and already on maximum doses of one or more oral agents and/or on insulin. Subjects will be randomized to one of two arms. In the standard arm, the goal will be to prevent hyper-or hypoglycemic symptoms and maintain HbA1c between 8-9% and prevent values above 9.5%. In the intensive arm, the goals will be to avoid hypoglycemia and achieve HbA1c levels within normal limits. The primary endpoint of the study is the occurrence of any of several major macrovascular events listed in the proposal: cardiovascular death, myocardial infarction, stroke, amputation due to ischemic gangrene, congestive heart failure, or invasive intervention for coronary or peripheral vessel disease. Other endpoints include retinopathy and renal events, clinical neuropathy, appearance or worsening of several macrovascular indicators (angina, claudication, etc.) and quality of life assessments. Twenty centers will recruit and follow 1700 patients for an average of 6 years. The study is approved to assess microvascular endpoints, including fundus photographs at entry and end of study. Diabetic retinopathy will also be assessed by annual examination, and interventions as needed to prevent visual loss such as laser treatment and cataract extraction will be counted as ophthalmologic end-points. As designed, the study will have 98% power to detect a 25% reduction in the combined endpoint of progression of existing retinopathy and appearance of new retinopathy. Concerns that respond to this synopsis shall furnish concise responses directed specifically to the requirements mentioned above and are invited to submit proposal and/or capability statements in an Original Plus Two (2) no later than ten (10) business days from the date of this announcement, December 22, 2006, due in COB Jan. 05, 2007. Written responses shall include complete description of services to be provided, containing sufficient technical information to permit agency analysis to establish bona fide capability to meet the stated requirements as listed above. Proposals And/Or Capabilty Statements Shall BE Sent To: (a) If mailing your capabilities through the U.S. Postal Service use the following address: National Institutes of Health, Office of Logistics and Acquisition Operations, OA, 6011 Executive Blvd. Rm. 529V, ATTN: Lloyd Garnes, Bethesda, MD 20892, telephone: 301-402-3341; fax: 301-480-3476. (b) If hand delivering, or using a courier service such as: UPS, FeDex, etc., use the following City, State and Zip Code: Rockville, MD 20852. Respondents will not be notified of the evaluation results. (c) Questions may be emailed to Lloyd Garnes at garnesl@od.nih.gov no later than Jan. 05, 2007.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01201832-W 20061224/061222220303 (fbodaily.com)
- Source
-
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