NCT07379333招募中3 期
A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2026年4月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in HbA1c at 36 weeks compared to baseline
研究概览
简要总结
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults aged 19 years or older
- •2. Diagnosed with type 2 diabetes
- •3. HbA1c level 7.0% ≤ HbA1c ≤ 10.0%
- •4. Stable administration of metformin (≥1,000 mg/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1
- •5. 20 kg/m2 ≤ BMI ≤ 45 kg/m2
- •6. Agree to the recommended exercise and diet regimen during this clinical trial
排除标准
- •1. Patients with a history of allergy or resistance to the investigational drug or background therapy
- •2. Patients diagnosed with a type of diabetes other than type 2 diabetes
- •3. Patients with uncontrolled severe diabetic complications
- •4. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis.
- •5. Patients with a history of diabetic coma or precoma
- •6. Those with a history of severe hypoglycemia
- •7. Those whose weight change > 5 kg
- •8. History of gastrointestinal disease or surgery
- •9. History of bariatric surgery
- •10. History of gallbladder disease
- •11. History of a disease that could affect the interpretation of HbA1c
- •12. History of acute or chronic pancreatitis or pancreatectomy
- •13. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2).
- •14. Uncontrolled hypertension
- •15. Severe infections or severe trauma
- •16. Malnutrition, starvation, or debility, as determined by the investigator.
- •17. Pituitary or adrenal insufficiency.
- •18. Tissue hypoxia, such as respiratory failure or shock.
- •19. History of alcoholism or drug abuse
- •20. History of malignant tumors
- •21. Heart failure, Ischemic heart disease, Severe cerebrovascular disease, TIA
- •22. Patients with one of the following clinical laboratory test results : Amylase or Lipase > 3 X ULN / FPG > 270 mg/dL
- •23. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT > 3 X ULN / Total bilirubin > 1.5 X ULN
- •24. Patients with moderate or severe renal impairment
- •25. History of Diabetic medications or weight-loss medications
- •26. Those who have participated in another clinical trial and received investigational drugs within 30 days
- •27. Pregnant or lactating women, or women of childbearing potential
- •28. Women of childbearing potential and men who do not consent to the use of the following contraceptive methods
- •29. Considered by investigator as not appropriate to participate in the clinical study with other reason.
研究组 & 干预措施
HM11260C
Experimental
Weekly administration by subcutaneous injection
干预措施: HM11260C (Drug)
Placebo
Placebo Comparator
Weekly administration by subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c at 36 weeks compared to baseline
时间窗: baseline, 36 weeks
次要结局
- Change from baseline in HbA1c at Week 24(baseline, 24 weeks)
- Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36(24, 36 weeks)
- Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36(24, 36 weeks)
- Change from baseline in FPG at Weeks 24 and 36(baseline, 24, 36 weeks)
- Proportion of subjects receiving rescue medication at Weeks 24 and 36(24, 36 weeks)
研究者
研究点 (1)
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