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Clinical Trials and Mechanistic Clinical Studies to Advance Adjunctive Therapies for Glucometabolic Control in Type 1 Diabetes

Deadlines are 5:00 PM (Eastern). No extensions will be granted.


Milestone Date Status
Letter of Intent Required Jun 21, 2022 Passed
Application Aug 23, 2022 Passed
Award Notification Feb 28, 2023 Next
Earliest Start Apr 01, 2023

Background & Purpose

Please click on the “RFA Announcement” link for complete information.

PURPOSE

JDRF is committed to accelerating the development of therapies that can complement insulin (i.e., adjunctive therapies) to improve glucose and metabolic outcomes in people with type 1 diabetes (T1D). To this end, we invite applications that propose (1) clinical trials to evaluate glucometabolic therapies in people with T1D or (2) mechanistic clinical studies to advance our knowledge of glucometabolic control in T1D toward the goal of future therapy development.

BACKGROUND

Insulin is required for all people with T1D. However, for most people, insulin monotherapy is insufficient for optimal glucose control. Further, a growing body of evidence is demonstrating the contribution of non-glucose metabolic imbalances like insulin resistance and obesity to long-term complications in T1D. Since insulin is powerless to address these and other challenges, adjunctive therapies must be developed to address both glucose and broader metabolic control. Despite the urgent need, only one adjunctive therapy (pramlintide) currently has regulatory approval in the US. Barriers to the development of adjunctive therapies for T1D glucometabolic control include an evidence gap for how existing and emerging therapies for type 2 diabetes, obesity, and other indications affect outcomes in T1D, lack of knowledge about specific mechanisms underlying glucometabolic imbalances in T1D, and limited commercial investment. This RFA is intended to support (1) clinical trials testing therapies—novel or repositioned, approved or in clinical development— for glucometabolic control in T1D, or (2) mechanistic clinical research to inform a better understanding of T1D glucometabolic imbalances to enable future therapy development.