Request for Information. Agents to be tested for Preclinical Efficacy in Prevention or Reversal of Type 1 Diabetes in Rodent Models. Type 1 Diabetes Preclinical Testing Program (T1D-PTP)

Notice Number: NOT-DK-08-012

Key Dates
Release Date:  February 21, 2008

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (

The NIDDK has recently awarded a contract to Biomedical Research Models, Inc to establish a rodent models based testing program for therapeutic interventions close to use in clinical trials for the prevention, delay, reversal or amelioration of type 1 diabetes.   The contractor has established colonies of two models of spontaneous type 1 diabetes (T1D), the BB rat and the NOD mouse, and protocols for testing agents that may prevent, slow or reverse T1D.  NIDDK invites scientists to provide information regarding promising therapeutics or intervention strategies which require further testing in these models in preparation for clinical trials.   Agents that may be used in both rodents and humans will be considered a priority.

The contractor is optimizing husbandry and treatment of the rodent models to allow interventions to be tested in rodent models approximating, as closely as possible, pre-diabetes in humans with evidence of autoimmunity and impaired glucose tolerance, and for reversal of diabetes at onset and prior to complete islet destruction.  In addition, the contractor may be able to obtain targeted mechanistic data that could be used to support biomarker development for a clinical trial.

Scientists wishing to recommend agents for testing (“sponsors”) should provide the following information:

  1. A rationale for the intervention including strong preliminary data showing evidence of efficacy in animal models of diabetes, or other autoimmune disease models, and/or in clinical trials in autoimmune diseases. 
  2. Recommendations about proper dose, route, and timing of the intervention.
  3. Methods for documenting that the intervention has the expected biochemical and/or physiological effects.
  4. Methods to assay the compound in the rodents to ensure the compound is stable and reaches expected levels.  
  5. Information, if available for mechanistic studies which could lead to biomarkers useful for monitoring efficacy in clinical trials.

If selected to participate in the program, the sponsor will be involved in selecting and developing the most appropriate testing regimens.  All data obtained under this program will be released to the public following completion of the study in a time frame that is determined by mutual agreement between the sponsor and the NIDDK.

If the sponsor is proposing the testing of a non-commercially available agent in development, the sponsoring investigator should provide a statement describing the intellectual property position of the investigator relevant to the therapeutic agent to be tested.

If the agent to be tested is the property of a commercial entity or company that is willing to provide the material for testing, the company must sign a Materials Transfer Agreement which will include a Statement of Intent by the company to further development towards clinical testing, if the agent demonstrates a mutually agreed-upon level of efficacy.  
It is important to emphasize that this program is not a funding opportunity and provides support solely for testing promising agents in the contractor’s facility.

Applications will be accepted at any time, but recommended target dates for expeditious review are April 30th and November 5th 2008.  Requests will be reviewed for scientific merit by an NIDDK appointed special review panel.  Acceptance into the program will be based on scientific merit, programmatic relevance, perceived translational potential and availability of resources. Format for application and additional information can be found by navigating from the T1D-PTP web page, ( )


Inquiries regarding this notice may be directed to:
Guillermo Arreaza-Rubin, M.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd. Rm. 6101
Bethesda, MD 20892-5460
Telephone: (301) 594-4724
FAX: (301) 480-2688

Lisa Spain, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd. Rm. 695
Bethesda, MD 20892-5460
Telephone: (301) 451-9871
FAX: (301) 480-2688

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