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HHS Recovery Act Recipient Reporting Readiness Tool

Step 4. Review and Copy the Grant Awards Data

TAGGS provides some – but not all – of the data needed for the Recipient Report. Recipients are responsible for directly collecting and reporting all required data to FederalReporting.gov. Data that HHS does not currently collect are highlighted in yellow. Do not copy this highlighted information. Please enter the appropriate data for your organization in these required fields. For assistance with entering these data please contact FederalReporting.gov.

You may capture the data HHS does provide by copying data from this screen and pasting it into the reporting format of your choice, such as the Excel spreadsheet template, the XML template, or by logging into the online form. For assistance with copying and pasting these data please e-mail our help desk at Readiness Help.

 

Award Detail for: A PROOF-OF-CONCEPT CLINICAL TRIAL OF XENIN-25 IN THE TREATMENT OF TYPE 2 DIABETES
WASHINGTON UNIVERSITY
DUNS Number: 068552207
CAMPUS BOX 1034
SAINT LOUIS, MO 63112
Recipient Report: Grant or Loan
Prime Recipient

Reporting Information
Award Type Award Number Final Report
Grant 1RC1DK086163-01 Recipient responsible for this data

Award Recipient Information
Recipient DUNS Number Recipient Account Number Recipient Congressional District
068552207 Recipient responsible for this data 1

Award Information
Funding Agency Code Awarding Agency Code Award Date
7529 7529 09-16-2009
Amount of Award Sub Account Number for Program Source (TAS)  
$ 499,999 Recipient responsible for this data
Program Source (TAS)* CFDA Number 
750883 93.701
Total Number of Sub Awards to Individuals Total Amount of Sub Awards to Individuals
Recipient responsible for this data Recipient responsible for this data
Total Number of Payments to Vendors less than $25,000/award Total Amount of Payments to Vendors less than $25,000/award
Recipient responsible for this data Recipient responsible for this data
Total Number of Sub Awards less than $25,000/award Total Amount of Sub Awards less than $25,000/award
Recipient responsible for this data Recipient responsible for this data
Award Description
DESCRIPTION (provided by applicant): This application addresses Broad Challenge Area (04) Clinical Research and specific Challenge Topic, 04-DK-106: Preservation/Recovery of endogenous insulin secretion. Diabetes is a serious and common metabolic disorder that afflicts 18 million Americans with an annual estimated cost of approximately $170 billion per year. The prevalence and incidence are increasing worldwide and this disease threatens to overwhelm the health care systems in the United States and other countries. Type 2 diabetes mellitus (T2DM) is the commonest form of diabetes accounting for well over 80% of cases. Current therapies for T2DM have significant limitations. Efficacy is frequently short lived and potentially serious side effects particularly in the cardiovascular system have been reported. Only a small proportion of diabetics achieve treatment targets and as a result, complications of T2DM are a major cause of morbidity and mortality. It has been known for some time that peptides produced and secreted by endocrine cells in the intestine play a major role in glucose metabolism in part by enhancing the insulin secretory response to glucose. Modulating the action or plasma concentrations of Glucagon- Like Peptide-1 (GLP-1), an intestinal peptide produced by intestinal L cells, is the basis for the action of two novel treatments of T2DM that have recently been approved and are now in widespread clinical use. There is thus considerable interest in determining whether other intestinal peptides could play a similar role. Although Glucose-dependent Insulinotropic Polypeptide increases glucose-stimulated insulin release in healthy individuals, this peptide product of the intestinal K cells is inactive in persons with T2DM. In the course of studies in transgenic mice engineered to lack K cells, we have determined that xenin-25, a second peptide product of the K cell, regulates insulin secretion specifically by enhancing insulin secretory responses to Glucose-Dependent Insulinotropic Polypeptide (GIP). The mechanism of xenin-25 action is also novel because preliminary results indicate that xenin-25 does not act directly on the pancreatic -cell. Rather, xenin-25 stimulates acetylcholine release from parasympathetic neurons that innervate the islets and this neurotransmitter then activates muscarinic receptors on the pancreatic islet -cell. This unexpected finding is not only of interest and importance for understanding the physiology of insulin secretion, but suggests a role for xenin-25 in the treatment of T2DM by enhancing endogenous insulin secretion. Based on these preliminary data, the present application proposes to conduct a proof-of-concept clinical trial in humans with T2DM and matched controls with normal glucose tolerance to determine whether xenin-25 either alone or in combination with GIP increases endogenous insulin secretion in T2DM. In Specific Aim 1 we will determine whether xenin-25 enhances the insulin secretory response to exogenously infused GIP and in Specific Aim 2 we will determine whether xenin-25 enhances the insulin secretory response to endogenously secreted GIP. The specific deliverables that will result from the Challenge Award include: 1. Definition of the role of xenin-25 in regulation of insulin secretion in normal subjects; 2. Definition of the role of xenin-25 in regulating insulin secretion in persons with T2DM; 3. Determination of the potential for xenin-25 or compounds that mimic its mode of action to be used in the treatment of T2DM. PUBLIC HEALTH RELEVANCE: The American Diabetes Association [Diabetes Care, 31:1-2, (2008)] points out that in the United States alone, greater than 17.5 million persons have been diagnosed with type 2 diabetes mellitus (T2DM) with an associated yearly economic burden exceeding $174 billion. The incidence of the disease is increasing rapidly on a worldwide basis with staggering impact on cost of healthcare and quality of life. Thus, there is an urgent need to develop new and improved approaches to the prevention and treatment of T2DM. The proposed studies will determine whether an intestinal peptide called xenin-25 could be used to treat T2DM. If so, this would have a dramatic positive impact on human health.

Project Information
Project Name or
Project/Program Title
Project Status Total Federal Amount ARRA Funds
Received/Invoiced
A PROOF-OF-CONCEPT CLINICAL TRIAL OF XENIN-25 IN THE TREATMENT OF TYPE 2 DIABETES Recipient responsible for this data Recipient responsible for this data
Number of Jobs Description of Jobs Created
Recipient responsible for this data Recipient responsible for this data
Quarterly Activities/Project Description
Recipient responsible for this data
 
Activity Code (NAICS or NTEE-NPC)
1Recipient responsible for this data2Recipient responsible for this data
3Recipient responsible for this data4Recipient responsible for this data
5Recipient responsible for this data6Recipient responsible for this data
7Recipient responsible for this data8Recipient responsible for this data
9Recipient responsible for this data10Recipient responsible for this data
Total Federal Amount of ARRA
Expenditure
Total Federal ARRA
Infrastructure Expenditure
Infrastructure Contact Name
Recipient responsible for this data Recipient responsible for this data Recipient responsible for this data
Infrastructure Contact Email Infrastructure Contact Phone Infrastructure Contact Phone Ext.
Recipient responsible for this data Recipient responsible for this data Recipient responsible for this data
Infrastructure Contact Street Address 1 Infrastructure Contact Street Address 2 Infrastructure Contact Street Address 3
CAMPUS BOX 1034 Not Available Recipient responsible for this data
Infrastructure City Infrastructure State Infrastructure ZIP Code+4
SAINT LOUIS MO 63112
Infrastructure Purpose and Rationale
Recipient responsible for this data

Primary Place of Performance
Street Address 1 Street Address 2 City
660 SOUTH EUCLID AVENUE Recipient responsible for this data ST. LOUIS
State Zip Code+4 Congressional District
MO 63110 Not Available
Country  
US

Recipient Highly Compensated Officers
Prime Recipient Indication of Reporting Applicability # Officer Name Officer Compensation
Recipient responsible for this data 1 Recipient responsible for this data Recipient responsible for this data
2 Recipient responsible for this data Recipient responsible for this data
3 Recipient responsible for this data Recipient responsible for this data
4 Recipient responsible for this data Recipient responsible for this data
5 Recipient responsible for this data Recipient responsible for this data

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USE IN THE RECIPIENT REPORT

The information provided by this tool is baseline data that the Recipient should include in the Recipient Report that must be submitted to FederalReporting.gov beginning October 1, 2009. The data from this tool can be cut and pasted directly into the Recipient Report.