Type 1 Diabetes
Conditions
Brief summary
This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. The purpose of this study is to compare efficacy and safety of THDB0206 injection with insulin lispro injection combined with insulin glargine injection U-100 in Chinese participants with T1DM.
Interventions
DRUGTHDB0206
Subcutaneous THDB0206 three times daily, with individualized dose adjustment.
DRUGInsulin Lispro
Subcutaneous insulin lispro three times daily, with individualized dose adjustment.
DRUGInsulin Glargine
Subcutaneous insulin glargine once daily, with individualized dose adjustment.
Sponsors
Tonghua Dongbao Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c at Week 26 | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26 | Week 26 |
| Change from Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26 | Week 26 |
Countries
China
Outcome results
None listed