A published article in Diabetes Care argues for the reestablishment of C‑peptide as a recognized primary endpoint for the full approval of type 1 diabetes therapies.
HARPERS FERRY, WV, UNITED STATES, April 22, 2026 /EINPresswire.com/ — The prominent journal Diabetes Care has released “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 presents a scientific and regulatory argument for bringing back C‑peptide as a primary endpoint for the full approval of disease-modifying therapies (DMTs) for type 1 diabetes (T1D).
The absence of this regulatory measure negatively affects the development of DMTs. Traditional glycemic endpoints such as HbA1c, and the risks of hypoglycemia and diabetic complications, take years to show changes after a T1D diagnosis in well-managed patients. Trials that show benefits in these outcomes need to last many years. The extended time and costs of such trials deter investors and small companies. The lack of approved treatments for newly diagnosed T1D is mainly due to the challenges of the disorder, but regulatory burdens also contribute to this need remaining unfulfilled. Without C‑peptide as an accepted endpoint, potential Disease‑Modifying Therapy (DMT) candidates undergo trials that are unnecessarily long, large, and costly—and some cannot progress at all. Reinstating C‑peptide as an approvable endpoint could not only speed up current programs but also facilitate the quicker development of treatment combinations, which may be needed to achieve curative approaches.
The main argument is clear. C‑peptide, co-secreted with insulin by the pancreatic beta cells destroyed in T1D, is a validated measure of remaining insulin secretion from the pancreas—better than insulin measurements themselves. Decades of evidence indicate that maintaining even low levels of C‑peptide significantly reduces hypoglycemia, improves glycemic control, and decreases long-term complication rates. The FDA used to accept C‑peptide as a clinical trial endpoint for full approval of T1D therapies aimed at preserving or restoring insulin secretion. That acceptance was once part of the FDA’s diabetes guidance. It was recently withdrawn—not due to doubts about C‑peptide’s validity or external expert opinions, but due to a broader requirement for more stringent validation trials. However, the scientific support for C‑peptide has only increased, and expert agreement continues to solidify.
Drs. Fleming, Mathieu, and Skyler bring together over a century of expertise in T1D research and drug development. Drs. Mathieu and Skyler have led key T1D trials and have served as Presidents of the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA), respectively. Dr. Fleming, formerly responsible for diabetes drug review at the FDA, has been a long-time advisor to many programs in the T1D field. He founded Kinexum in 2003, focusing on R&D in the cardiometabolic area, especially T1D.
The authors will participate in a webinar sponsored by The Kitalys Institute in June, discussing potential therapeutic and technological solutions for T1D. Details will be available soon on The Kitalys Institute website.
Key points:
• C‑peptide directly measures beta cell function—the loss of which defines T1D
• Its clinical value is backed by decades of evidence
• The FDA once accepted C‑peptide as an endpoint; this acceptance was withdrawn without scientific justification
• Current endpoint requirements block a whole category of promising DMTs
• Reinstating it could shorten timelines, lower costs, and expand treatment options 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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Comments
14 responses to “A Plea to FDA and EMA: Remove Barriers to Approving Type 1 Diabetes Treatments”
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Looks like the FDA and EMA have decided that waiting for a village to raise a child is a faster approach than approving these Type 1 diabetes treatments. Maybe they think we enjoy a bit of suspense in our lives? 🤷♂️
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Seems like getting the FDA and EMA to approve diabetes treatments is as easy as teaching a cat to fetch—good luck with that! 🙄🤷♂️
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Sure, because who wouldn’t want to navigate a bureaucratic maze just to get a lifesaving treatment, right? 🙄 Cheers to progress, or should I say, *slow-motion* progress in the land of regulations! 🥳
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Looks like the FDA and EMA have decided that C-peptide is just too mainstream to be a proper endpoint. Maybe they should try a trendy new metric, like how many people can fit in a café during rush hour! 😂
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Seems like the FDA and EMA are busy playing hard to get with C-peptide—guess they think a little regulatory red tape adds to the drama of diabetes treatment. 🤷♂️ It’s not like patients need timely therapies or anything, right? 🥴
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Seems like the FDA and EMA are on a permanent coffee break while we’re waiting for a simple C-peptide approval. Maybe they think the cure for T1D will magically turn up while they’re contemplating the color of their office walls. 🤔☕️
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Looks like the FDA and EMA are busy perfecting their art of procrastination while millions are waiting for a glimmer of hope in T1D treatments. Who knew red tape could be such a fashionable accessory? 🤷♂️
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Just what we needed, more red tape in healthcare; because who wouldn’t want their life-saving treatments to take an eternity to get approved? 🤦♂️ C’mon, it’s not like patients are waiting or anything… 🙄
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Seems like getting the FDA and EMA to approve something is easier than finding a decent cuppa in Italy. 🤷♂️ Maybe if they threw in some pasta, they’d hurry things along! 🍝
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Seems like the FDA and EMA are taking their sweet time perfecting the art of procrastination; maybe they think it’s an Olympic event. 🙄 Time to wake up and smell the insulin, chaps!
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Oh, brilliant! Because who doesn’t love waiting an eternity for treatments while the bureaucrats play chess with our health? 🕰️ Just what we need—more red tape to wrap around a cure! 😂
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Seems like the FDA and EMA are busy with their tea and biscuits while patients wait for a miracle cure. Typical, innit? 🍵🙄
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C‑peptide as a primary endpoint? Brilliant! Next, let’s suggest they bring back the rotary phone while we’re at it. 😏📞
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Looks like the FDA and EMA are more interested in a game of regulatory hopscotch than actually helping people with T1D. Maybe we should just start a crowdfunding campaign for common sense instead? 🤦♂️
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