REQUEST FOR ADDITIONAL CLINICAL SITES TO PARTICIPATE IN A TRIAL OF 
TREATMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESECNTS

Release date:  May 2, 2002

Notice:  NOT-DK-02-005

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)

The National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) seeks additional clinical sites to participate in a multi-arm, 
multi-center trial to study the treatment of type 2 diabetes in the 
pediatric population. Type 2 diabetes has been traditionally viewed as 
a disease of adults, however, recent epidemiologic data reveal an 
increasing number of cases of type 2 diabetes in the pediatric 
population, especially among adolescents and in certain minority 
populations. The increase of type 2 diabetes in children and 
adolescents is presumed to be a consequence of widespread obesity and 
decreased physical activity.

When children develop diabetes, efficacious therapy is needed to 
maintain euglycemia in order to prevent the development of 
complications. The drugs currently approved for use in adults with type 
2 diabetes have generally not been systematically studied in children. 
Thus, treatment options for those children diagnosed with type 2 
diabetes are restricted by the lack of data on the use of such 
pharmacologic agents.  Optimal treatment of type 2 diabetes in 
children, as well as in  adults, should go beyond merely achieving 
euglycemia. Ideally, therapy would reverse insulin resistance and 
preserve or improve beta cell function. However, little is known about 
which particular classes of agents used to treat type 2 diabetes might 
be advantageous in helping to maintain insulin secretion and preventing 
the inexorable slide to insulin treatment which ultimately 
characterizes type 2 diabetes.  The goal of this clinical trial will be 
to help establish appropriate and effective treatment regimens for 
children with type 2 diabetes.

Planning for this trial has begun under a cooperative agreement funded 
under RFAs DK01-010 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-010.html) and 
DK01-011 (http://grants.nih.gov/grants/guide/rfa-
files/RFA-DK-01-011.html) which invited applications for clinical sites 
and a Coordinating Center.. The cooperative agreement is funded for 7 
years, anticipating three phases: 1) planning, 2) recruitment and 
study, and 3) analysis. Currently, a Steering Committee, composed of 
the Principal Investigators from the clinical sites, the Principal 
Investigator of the Coordinating Center, an NIDDK representative, and 
several outside experts, is beginning protocol development for this 
trial. However, additional, clinical sites are needed to assure 
adequate power, as well as geographic and racial/ethnic diversity.   It 
is the intent of the NIDDK to add additional clinical sites in a timely 
manner, so that these new sites can participate in the planning process 
for the trial. Awards to additional clinical sites will be made through 
subcontracts from the Coordinating Center.  Funding is available in the 
first year for travel of the principal investigator to planning 
meetings, as well as for effort commensurate with the level of 
participation in protocol development.  Once the trial begins, the 
subcontracts will provide funds to each center to support personnel, 
supplies, equipment, communication, travel and patient care costs 
associated with the study. The award will depend on the requirements of 
the protocol ultimately designed by the Steering Committee. It is 
anticipated that Principal Investigators from the new sites will serve 
on the Steering Committee.

Requests to participate may be submitted by institutions in the United 
States and Canada. This geographic constraint is necessary because of 
the need for close communication and meetings among members of the 
Steering Committee.  Requests should be submitted on a PHS 398 
(http://grants.nih.gov/grants/forms.htm).   Each request should have a 
face page, abstract, biographical sketch, description of resources, and 
a research plan. The biosketch should include a description of all 
active research support and a description of recently completed 
projects. A budget is not needed. The research plan should not exceed 5 
pages and should include: 1) a brief proposal for the design of the 
trial, with a discussion of the rationale for selecting this design, as 
well as the choice of outcome measures, 2) a detailed description of 
the proposed trial population at the site (including the number of 
children with newly diagnosed type 2 diabetes seen annually, the number 
of children with type 2 diabetes currently followed, the number of 
children diagnosed within the past year who could be expected to be 
recruited into the trial, the anticipated drop out rate, and the 
gender, racial and ethnic composition of the population),  and 3) a 
description of the Principal Investigator"s experience in multi-center 
or large clinical trials. The investigator should discuss all trials in 
which he/she played a significant role, and include an explanation of 
that role, as well as a description of the numbers (or percent) of 
eligible patients successfully recruited to these trials.  Human 
subject issues, as required in the instructions for the PHS 398, must 
be addressed. Requestors must also document their willingness to 
participate on the Steering Committee and appropriate subcommittees, 
work cooperatively with the other members of the Steering Committee, 
and follow the common protocols established cooperatively by the 
Steering Committee.  Details regarding the "Terms and Conditions" of 
this cooperative agreement can be found in the original RFA. 

Requests (2 copies) should be submitted no later than June 7, 2002 to:

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Blvd., Rm. 699, MSC 5460
Bethesda, MD 20892-5460
(for courier service, use zip code 20817)
Telephone: (301) 594-0021
FAX: (301) 480-3503
E-mail: [email protected]

All inquiries should also be directed to Dr. Linder.

Requests will be reviewed by a panel convened by the Coordinating 
Center (the George Washington University), and evaluated according to 
the following criteria:

o completeness of the request
o ability of the potential site to recruit and retain subjects for the 
trial
o need for geographic and racial/ethnic diversity within the study 
population
o ability of the investigator to make an intellectual contribution to 
the collaborative effort

It is anticipated that six to ten additional sites will be supported.  
Investigators submitting requests will be eligible to receive travel 
support to participate in a meeting in early July to discuss protocol 
design.  Subcontracts will be awarded once it has been determined 
exactly how many patients will need to be recruited. 

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