Just Published in Diabetes Care: A Call for FDA and EMA to Remove Roadblock to Approval of Type 1 Diabetes Therapies

Diabetes Care published an article making the case for reinstating C‑peptide as an accepted primary endpoint for full approval of therapies for type 1 diabetes.

HARPERS FERRY, WV, UNITED STATES, April 22, 2026 /EINPresswire.com/ -- The leading journal Diabetes Care has published "The Importance of C‑Peptide for Developing T1D Disease‑Modifying Therapies,” authored by G. Alexander Fleming (Kinexum), Chantal Mathieu (UZ Leuven), and Jay Skyler (Diabetes Research Institute, University of Miami). The article makes a direct scientific and regulatory case for reinstating C‑peptide as an accepted primary endpoint for full approval of disease-modifying therapies (DMTs) for type 1 diabetes (T1D).

This regulatory gap has a direct negative impact on the development of DMTs. Conventional glycemic endpoints like HbA1c and risks of hypoglycemia and diabetic complications take years to change after T1D diagnosis in people with well-managed T1D. Trials that can demonstrate benefit in these outcomes must extend over many years. The time and costs of such trials are prohibitive to investors and small companies. The fact that there are no approved treatments for recently diagnosed T1D is largely due to the enormous challenge of the underlying disorder, but the high regulatory burden has contributed to this persistent high unmet need. Without C‑peptide as an accepted endpoint, promising Disease‑Modifying Therapy (DMT) candidates face trials that are longer, larger, and costlier than necessary—and some cannot be developed at all. Reinstating C‑peptide as an approvable endpoint would not only accelerate existing programs; it would also open the door to faster development of treatment combinations, which will likely be required to achieve curative approaches.

The core argument is straightforward. C‑peptide—co-secreted with insulin by the pancreatic beta cells destroyed in T1D—is a highly validated measure of remaining insulin secretion from the pancreas—superior to measuring insulin itself. Decades of evidence have demonstrated that preserving even modest C‑peptide levels meaningfully reduces hypoglycemia, improves glycemic control, and lowers rates of long-term complications. Critically, the FDA once accepted C‑peptide as a clinical trial endpoint for full approval of T1D therapies aimed at preserving or restoring insulin secretion. That acceptance was incorporated in the FDA’s diabetes guidance. This policy was more recently withdrawn—not because of evidence against C‑peptide's validity or outside expert advice, but as the result of a general imposition of a more burdensome validation trial endpoint process. Yet, the scientific basis for C-peptide has only grown, and the expert consensus has continued to strengthen.

Drs. Fleming, Mathieu, and Skyler collectively represent more than a combined century of expertise in T1D research and drug development. Drs. Mathieu and Skyler not only have led landmark T1D trials, but have served, respectively, as Presidents of the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA). Dr. Fleming was responsible for diabetes drug review at the FDA and has, for decades, been an advisor to many programs in the T1D space. He founded Kinexum in 2003, specializing in supporting R&D in the cardiometabolic space, especially T1D.

The authors will be part of a webinar sponsored by The Kitalys Institute in June. The panel will cover all potential therapeutic and technological solutions for T1D. More information will be posted on The Kitalys Institute website shortly.

Key points:
• C‑peptide directly measures beta cell function—the process whose loss defines T1D
• Its clinical value is supported by decades of accumulating evidence
• The FDA previously accepted C‑peptide as an endpoint; that acceptance was withdrawn without a scientific basis for doing so
• Current endpoint requirements are effectively blocking an entire category of promising DMTs
• Reinstatement would shorten timelines, reduce costs, and expand the viable treatment pipeline for millions of patients

"The Importance of C‑Peptide for Developing T1D Disease‑Modifying Therapies" is published in Diabetes Care at https://doi.org/10.2337/dci26-0015.

Emma Snyder
Kinexum
emmasnyder@kinexum.com

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