NCT07282054已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Change from Baseline in HbA1c at Week 26
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
THDB0206 Injection
Experimental
干预措施: THDB0206 (Drug)
THDB0206 Injection
Experimental
干预措施: Insulin Glargine (Drug)
Insulin Lispro Injection
Active Comparator
干预措施: Insulin Lispro (Drug)
Insulin Lispro Injection
Active Comparator
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change from Baseline in HbA1c at Week 26
时间窗: Week 26
次要结局
- 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)
研究者
研究点 (1)
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