Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes

NCT ID: NCT07282054

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2025-01-24

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

THDB0206 Injection

Group Type: EXPERIMENTAL

THDB0206

Intervention Type: DRUG

Subcutaneous THDB0206 three times daily, with individualized dose adjustment.

Insulin Glargine

Intervention Type: DRUG

Subcutaneous insulin glargine once daily, with individualized dose adjustment.

Insulin Lispro Injection

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: DRUG

Subcutaneous insulin lispro three times daily, with individualized dose adjustment.

Insulin Glargine

Intervention Type: DRUG

Subcutaneous insulin glargine once daily, with individualized dose adjustment.

Interventions

THDB0206

Subcutaneous THDB0206 three times daily, with individualized dose adjustment.

Intervention Type: DRUG

Insulin Lispro

Subcutaneous insulin lispro three times daily, with individualized dose adjustment.

Intervention Type: DRUG

Insulin Glargine

Subcutaneous insulin glargine once daily, with individualized dose adjustment.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanjing Drum Tower hospital

Nanjing, , China

Countries

China

Other Identifiers

THDB0206L01

Identifier Type: -

Identifier Source: org_study_id