Roche Presents Positive Phase II Data for Acmopatide in Type 1 Diabetes at ADA 2026

Roche's Acmopatide Shows Positive Phase II Results in Type 1 Diabetes

Roche presented positive data from its randomized Phase II study of acmopatide in type 1 diabetes patients with overweight or obesity at the American Diabetes Association (ADA) conference 2026. The treatment improved blood glucose management, reducing A1C levels by 0.34% from baseline, with 56% of participants achieving an A1C below 7%. Acmopatide also led to dose-dependent weight loss of up to 7% and reduced insulin use by up to 15% compared to placebo, and was generally well tolerated with no reported safety concerns.

• Acmopatide demonstrated significant improvement in blood glucose management, achieving a 0.34% reduction in A1C from baseline. Notably, 56% of patients reached the recommended A1C target of below 7%, highlighting its potential to enhance glycemic control in type 1 diabetes patients.
• Beyond its impact on blood glucose, acmopatide also showed dose-dependent weight loss of up to 7% and reduced insulin requirements by up to 15%. These additional benefits are crucial for addressing common comorbidities and alleviating treatment burdens associated with type 1 diabetes.
• The treatment was generally well tolerated, with no reported safety concerns, indicating a promising safety profile. As the first incretin therapy specifically developed for type 1 diabetes, acmopatide offers a potential new therapeutic class beyond traditional insulin treatments.

Roche's Acmopatide: A Novel Incretin Therapy for Type 1 Diabetes

Recent clinical investigations in type 1 diabetes have demonstrated significant advances across multiple therapeutic modalities, with several studies showing promising safety and efficacy profiles. The Phase 1-2 study of zimislecel (VX-880-101 FORWARD Trial) represents a landmark achievement in cell-based therapy, where 14 participants receiving allogeneic stem cell-derived islet cells achieved remarkable outcomes. All participants demonstrated engraftment and restored islet function evidenced by C-peptide detection, with 83% achieving insulin independence at day 365. While neutropenia occurred in three participants and two deaths were reported (one from cryptococcal meningitis, one from dementia progression), the trial established proof-of-concept for functional β-cell replacement.

The teplizumab studies have consolidated evidence for immunomodulatory intervention in stage 2 type 1 diabetes, with multiple investigations confirming its ability to delay disease progression by a median of two years while preserving β-cell function (adjusted HR = 0.41; 95% CI 0.22-0.78). Real-world experience from Italian compassionate use programs demonstrated overall tolerability, though cytokine-release syndrome and lymphopenia were observed in some patients. Advanced automated insulin delivery systems, particularly the MiniMed 780G studies, showed substantial improvements in glycemic control with time-in-range increasing from 54.4% to 71.4% in youth and 66.5% to 80.2% in adults, while maintaining acceptable safety profiles with minimal increases in hypoglycemia risk.

Adjunctive therapies have emerged as valuable treatment options, with GLP-1 receptor agonists demonstrating significant cardiovascular and renal benefits in large-scale analyses of 174,678 patients, showing reduced risks of major adverse cardiovascular events (HR: 0.85) and end-stage kidney disease (HR: 0.81) without increasing diabetic ketoacidosis or severe hypoglycemia risks. The comparative study of GLP-1 receptor agonists versus SGLT2 inhibitors revealed distinct therapeutic profiles, with GLP-1 therapy providing superior HbA1c and weight reduction alongside LDL cholesterol improvements, while SGLT2 inhibitors showed benefits in renal markers and insulin dose reduction. Statin therapy for primary prevention demonstrated meaningful reductions in all-cause mortality and major cardiovascular disease, with absolute risk reductions being most pronounced in women, patients ≥40 years, and those with higher baseline cardiovascular risk profiles.

Afrezza's Inhaled Insulin: Comparing Efficacy and Satisfaction in T1D

Several investigational therapies show promise as adjunctive treatments to standard insulin therapy in Type 1 diabetes, with varying efficacy profiles and safety considerations. While intensive insulin therapy remains the established standard of care based on landmark trials like DCCT/EDIC, emerging therapies offer potential benefits for specific patient populations and clinical scenarios.

• SGLT2 inhibitors demonstrate superior renal protection compared to GLP-1 receptor agonists, with eGFR preservation of +3.5 ml/min per 1.73 m² over 5 years and reduced risks of heart failure (RR 0.44) and CKD development (RR 0.49), though they carry increased risks of diabetic ketoacidosis (RR 2.08) and urinary tract infections (RR 2.27)

• GLP-1 receptor agonists provide greater glycemic improvement than SGLT2 inhibitors with HbA1c reduction of -5.4 mmol/mol (-0.5%) versus -2.6 mmol/mol (-0.2%), while offering superior cardiovascular outcomes including 15% reduction in major adverse cardiovascular events and 19% reduction in end-stage kidney disease risk

• Teplizumab, the most recent FDA-approved investigational therapy (November 2022), represents the first disease-modifying treatment for Type 1 diabetes by slowing beta-cell decline in stage 2 and early stage 3 patients, potentially delaying progression to clinical diabetes

• Metformin as adjunctive therapy shows significant improvements in glycemic control with meaningful HbA1c reductions (p<0.001) and prevention of weight gain associated with intensive insulin therapy, particularly in adolescent patients above 12 years of age

• Advanced glucose monitoring systems like FreeStyle Libre demonstrate substantial HbA1c improvements (-0.75% in T1D at 3 months) that are maintained at 12 months, with greatest benefits observed in patients with baseline HbA1c >7.5%, while patients with HbA1c >10% showed dramatic reductions of -4.66%

• Intensive insulin therapy, while remaining standard of care, carries well-documented risks including increased severe hypoglycemia, hypoglycemia unawareness, and weight gain, with conventional therapy associated with 2-fold increased retinopathy risk and 5-fold increased cataract risk when applied longer than 3.5 years

Addressing Unmet Needs and Limitations in Type 1 Diabetes Treatment

Despite decades of research and therapeutic advances, type 1 diabetes treatment faces significant challenges that leave patients with substantial unmet medical needs. Current insulin-based approaches fail to adequately replicate normal pancreatic function, and emerging therapeutic strategies continue to encounter fundamental limitations.

• Inadequate glycemic control with standard insulin therapy - Standard insulin regimens cannot maintain blood glucose concentrations within the narrow physiological range achieved by normal pancreatic beta cells, failing to provide satisfactory glycemic control in the majority of patients

• Limited treatment options and heavy disease burden - Close to 2 million individuals in the U.S. remain dependent on multiple daily insulin injections or continuous pump infusion with no oral medications available, while the disease continues to cause severe complications and increased mortality despite modern techniques

• Poor achievement of metabolic targets in pediatric populations - Few pediatric patients with T1D achieve their metabolic targets, requiring comprehensive management that addresses glucose control, insulin resistance, beta-cell preservation, quality of life, and cardiovascular risk factors

• Insufficient efficacy of immunomodulatory approaches alone - Decades of focusing solely on immunosuppressive and immunomodulatory therapies have proven inadequate after disease onset, requiring combination approaches that also address beta cell health and function

• Challenges in achieving permanent disease remission - Permanent remission of type 1 diabetes has not been satisfactorily achieved due to the difficulty of overcoming the persistent autoimmune response that destroys regenerated beta cells

• Limited availability and durability of islet transplantation - Islet cell replacement therapy is constrained by shortage of pancreas donors, limited availability of human islets from cadaveric sources, and challenges with encapsulation material stability and longevity in vivo

• Lack of physiologically responsive insulin delivery systems - Current insulin gene therapy approaches lack regulatory systems that can express and release insulin in response to glucose with satisfactory kinetics, failing to replicate normal pancreatic function