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

NCT07282054 | Completed Phase 3

• 1 other identifier: THDB0206L01
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in HbA1c at Week 26

  Week 26

Secondary Outcomes (2)

• 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

Study Arms (2)

THDB0206 Injection

EXPERIMENTAL

Drug: THDB0206; Drug: Insulin Glargine

Insulin Lispro Injection

ACTIVE COMPARATOR

Drug: Insulin Lispro; Drug: Insulin Glargine

Interventions

Insulin Lispro DRUG

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

Insulin Lispro Injection

Insulin Glargine DRUG

Subcutaneous insulin glargine once daily, with individualized dose adjustment.

Insulin Lispro Injection; THDB0206 Injection

THDB0206 DRUG

Subcutaneous THDB0206 three times daily, with individualized dose adjustment.

THDB0206 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants, 18 to 75 years of age at informed consent (inclusive).
• BMI between 18.0 and 30.0 kg/m² (inclusive).
• T1DM diagnosed ≥6 months per WHO diabetes classification (2019).
• On insulin therapy ≥6 months prior to screening.
• 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:
• 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).
• Premixed insulin ≥2 times per day.
• Screening HbA1c between 7.0% and 11.0% (inclusive), measured by the central laboratory.

You may not qualify if:

• Diabetes other than T1DM.
• History of pancreatectomy.
• Prior pancreatic and/or islet cell transplantation.
• ≥1 episode of Level 3 hypoglycemia within 6 months before screening (requires external assistance).
• Hepatic or renal impairment at screening (per local laboratory reference ranges):
• AST or ALT ≥3× ULN; and/or
• TBL ≥2× ULN (except Gilbert syndrome); and/or
• Estimated creatinine clearance \<45 mL/min (Cockcroft-Gault).
• Known hypersensitivity/allergy to study insulin products or excipients, or to any component of the standardized test meal.
• Blood transfusion or major blood loss within 3 months before screening; hemoglobinopathies, moderate-severe anemia, or other conditions that may interfere with HbA1c measurement.
• 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).
• 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.
• Use within 3 months before screening, or current use, of traditional medicines (herbal or proprietary Chinese medicines) with known glucose-lowering effects.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Nanjing Drum Tower hospital

Nanjing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: April 13, 2022
• Primary Completion: January 23, 2025
• Study Completion: January 24, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)