Limited Competition: Continuation of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study (U01) | RFA DK 16 511

Opportunity Information: Apply for RFA DK 16 511

This funding opportunity, titled "Limited Competition: Continuation of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study (U01)" (Funding Opportunity Number RFA-DK-16-511), is a National Institutes of Health (NIH) discretionary grant intended to support the ongoing conduct of the GRADE Study. The award mechanism is a cooperative agreement (U01), which typically means NIH will have substantial programmatic involvement in the project’s oversight and coordination rather than operating as a hands-off funder. The core purpose is straightforward: continue the treatment and follow-up of participants who were already recruited into the GRADE pragmatic clinical trial, so that the study can complete its long-term comparison of diabetes treatment strategies.

GRADE itself is described as a pragmatic, unmasked clinical trial focused on real-world clinical decision-making in type 2 diabetes. In practical terms, "pragmatic" signals that the study is designed to reflect routine care settings and decisions rather than an artificial, highly controlled environment, while "unmasked" indicates that participants and investigators generally know which treatment is being used (as opposed to a blinded design). The scientific aim is to compare several commonly used glucose-lowering medications when added to metformin, which is widely used as a first-line therapy in type 2 diabetes. The primary emphasis is on long-term glucose-lowering effectiveness, meaning the study is geared toward understanding which medication combinations best sustain glycemic control over time rather than only short-term changes. The broader outcome is clinically oriented: generate evidence that helps clinicians choose the most appropriate add-on medication to metformin for patients with type 2 diabetes, using head-to-head comparative effectiveness data rather than relying mainly on separate trials or indirect comparisons.

The opportunity is labeled a "limited competition," and the listing indicates an expectation of only one award. That framing usually implies the continuation funding is meant for a specific established study infrastructure (such as the existing trial network, coordinating centers, and clinical sites) rather than inviting many new groups to propose entirely new projects. In other words, this FOA is positioned as continuation support to carry an ongoing major clinical trial forward, ensuring participant treatment and longitudinal follow-up can proceed as planned.

Eligibility is broad across U.S.-based organizational types, spanning many segments of the public, nonprofit, and private research ecosystem. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws firm lines on foreign involvement: non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, which generally means certain discrete elements of the project may be carried out abroad under NIH rules even though the applicant organization must be domestic.

From an administrative standpoint, the opportunity sits under the health-related activity area (Food and Nutrition, Health) and is tied to CFDA number 93.847. The posting lists an original closing date of 2016-12-07 and a creation date of 2016-07-28, indicating this was a time-limited call aligned with the timeline needs of the ongoing GRADE trial. An award ceiling is not specified in the provided text, suggesting applicants would need to consult the full FOA for budget limits, allowable costs, and the precise scope of funded activities. Overall, the opportunity is best understood as continuation funding designed to keep a large, clinically meaningful comparative effectiveness trial on track, with the end goal of producing high-quality evidence on which metformin add-on therapies most effectively maintain glycemic control over the long term in type 2 diabetes.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Continuation of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2016-07-28.
• Applicants must submit their applications by 2016-12-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 16 511

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