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

A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: THDB0206; Drug: Insulin Glargine; Drug: Insulin Lispro

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin Lispro Injection	Drug: Insulin Glargine; Subcutaneous insulin glargine once daily, with individualized dose adjustment.; Drug: Insulin Lispro; Subcutaneous insulin lispro three times daily, with individualized dose adjustment.
Experimental: THDB0206 Injection	Drug: THDB0206; Subcutaneous THDB0206 three times daily, with individualized dose adjustment.; Drug: Insulin Glargine; Subcutaneous insulin glargine once daily, with individualized dose adjustment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in HbA1c at Week 26	Week 26

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Insulin, Short-Acting; Insulin Glargine; Insulin Lispro
• Other Study ID Numbers: THDB0206L01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No