New insulin shows promise for type 1 diabetes in chinese trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female participants, 18 to 75 years of age at informed consent (inclusive). 2. BMI between 18.0 and 30.0 kg/m² (inclusive). 3. T1DM diagnosed ≥6 months per WHO diabetes classification (2019). 4. On insulin therapy ≥6 months prior to screening. 5. Stable insulin regimen ≥3 months prior to screening (no change in insulin class), with or without metformin or alpha-glucosidase inhibitors; willing to follow multiple daily injections: 1. Intermediate/long-acting insulin once or twice daily (e.g., NPH, glargine, detemir, degludec); plus prandial insulin 1\~3 times daily (or as per usual diet) (e.g., regular human insulin, lispro, aspart, glulisine). 2. Premixed insulin ≥2 times per day. 6. Screening HbA1c between 7.0% and 11.0% (inclusive), measured by the central laboratory. Exclusion Criteria: 1. Diabetes other than T1DM. 2. History of pancreatectomy. 3. Prior pancreatic and/or islet cell transplantation. 4. ≥1 episode of Level 3 hypoglycemia within 6 months before screening (requires external assistance). 5. Hepatic or renal impairment at screening (per local laboratory reference ranges): 1. AST or ALT ≥3× ULN; and/or 2. TBL ≥2× ULN (except Gilbert syndrome); and/or 3. Estimated creatinine clearance \<45 mL/min (Cockcroft-Gault). 6. Known hypersensitivity/allergy to study insulin products or excipients, or to any component of the standardized test meal. 7. Blood transfusion or major blood loss within 3 months before screening; hemoglobinopathies, moderate-severe anemia, or other conditions that may interfere with HbA1c measurement. 8. Use of oral antihyperglycemics within 3 months before screening (except metformin and alpha-glucosidase inhibitors), or use of non-insulin injectables (e.g., GLP-1 receptor agonists). 9. Systemic corticosteroid therapy for ≥14 consecutive days within 3 months prior to screening (including IV, IM, SC, or oral routes; excluding topical, intraocular, intranasal, intra-articular, and inhaled use), or systemic corticosteroid therapy within 8 weeks prior to screening (except physiologic replacement for adrenal insufficiency), or anticipated need for prolonged systemic corticosteroid therapy during the study. 10. Use within 3 months before screening, or current use, of traditional medicines (herbal or proprietary Chinese medicines) with known glucose-lowering effects.