Type 1 diabetes is a chronic autoimmune disease in which the immune system destroys insulin-producing beta cells, resulting in absolute insulin deficiency and lifelong insulin replacement needs.
C-peptide is described as a key biomarker for beta cell function in type 1 diabetes and a potential surrogate endpoint for drug approval. Current trial endpoints remain difficult for disease-modifying therapies.
The first clinical trial of an AAV gene therapy for type 1 diabetes is set to begin this year. The 52-week phase 1 PROGRESS study will test one-time intramuscular KRIYA-839 in adults with A1c above 7% using automated insulin delivery systems.
Evidence on ketogenic diets remains limited for psychiatric disorders and diabetes, while a systematic review in overweight and obese women with PCOS found significant short-term improvements. Experts said more controlled, long-term studies are needed.
Studies on immune checkpoint inhibitor therapy found pretreatment biomarkers strongly predicted checkpoint inhibitor-associated autoimmune diabetes, while hyperglycemia during treatment was common and did not worsen disease progression.
Sana Biotechnology named Brian Piper executive vice president and CFO as it advanced SC451 and SG293. The company reported a fourth-quarter loss of $59 million and cash of $138 million.
The FDA cleared MiniMed Flex, a screen-free insulin pump controlled by smartphone, and granted breakthrough device designation to Portal Diabetes’ implantable Portal Pump system. Portal Diabetes also began a Phase I study of Portal Insulin, while MiniMed said Flex supports its latest algorithm, sensors and infusion sets.
CRISPR Therapeutics reported a $581.6 million net loss in 2025 with revenue of just $3.5 million, while continuing to advance its gene-editing pipeline including the approved CASGEVY therapy and next-generation CAR T cell programs. The company maintains strategic partnerships and expects current funds to support operations for at least 24 months.
Diamyd Medical anticipates March 2026 interim results from its Phase 3 diabetes trial that could support a BLA pathway. Capricor Therapeutics awaits an August 2026 FDA decision on its Duchenne muscular dystrophy treatment BLA. Bicara Therapeutics prepares for Phase 3 study initiation of its oncology candidate toward future BLA submission.
Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.
Nektar Therapeutics is advancing its immunology pipeline with plans to initiate Phase 3 trials for REZPEG in atopic dermatitis next quarter, following positive Phase 2b results. The company recently completed a large equity raise to support its regulatory T cell-focused programs.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07596160 |
Individualized Exercise Consultation in Type 1 Diabetes |
NOT_YET_RECRUITING | NA |
| NCT07594145 |
Precision T1D Platform - New Therapies for Cardio-Renal Complications |
NOT_YET_RECRUITING | PHASE2 |
| NCT07593625 |
Evaluating Glucose Control Using a Next-Generation AID Algorithm in Adults With T1D |
NOT_YET_RECRUITING | NA |
| NCT07593105 |
Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes |
COMPLETED | NA |
| NCT07591077 |
SGLT2 Adjunct in T1D |
COMPLETED | PHASE2/PHASE3 |
| NCT07573228 |
Impact of Obesity on Microvascular Insulin Action and Cardiorespiratory Fitness in Type 1 Diabetes |
RECRUITING | NA |
| NCT07564752 |
The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes |
RECRUITING | |
| NCT07560813 |
NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes |
NOT_YET_RECRUITING | NA |
| NCT07550608 |
Effects of Pre-Exercise Basal Insulin Manipulation on Glucose Dynamics in Females vs. Males With Type 1 Diabetes |
COMPLETED | NA |
| NCT07501338 |
Early Automated Insulin Delivery (AID) Pilot for Newly Diagnosed T1D |
NOT_YET_RECRUITING | NA |
