NCT06635057已完成4 期
A Phase 4, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Effectiveness and Safety of Tirzepatide Once Weekly in Adult Participants With Type 2 Diabetes During Ramadan
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 56
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of the study is to investigate whether tirzepatide can be effectively started before Ramadan and used per label in participants with Type 2 Diabetes during the fasting month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of uncontrolled Type 2 Diabetes based on the World Health Organization classification or other locally applicable diagnostic standards, and who intend to fast during Ramadan
- •Have HbA1c ≥7% within 30 days prior to screening
- •Are glucagon-like peptide-1 receptor agonist (GLP-1 RA) naïve
- •Have had stable body weight self-reported change ≤5 kilograms (kg) during the 90 days prior to screening
- •Have body mass index ≥25 kilograms per square meter (kg/m2) at screening
排除标准
- •Have Type 1 Diabetes or gestational diabetes
- •Have a history of chronic or acute pancreatitis
- •Have acute or chronic hepatitis
- •Have evidence of a significant, uncontrolled endocrine abnormality
- •Have a history of an active or untreated malignancy
- •Have New York Heart Association Functional Classification IV congestive heart failure
- •Have been treated with insulin within two weeks prior to screening
研究组 & 干预措施
Tirzepatide
Experimental
Participants will receive tirzepatide subcutaneously (SC)
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)
次要结局
- Percent Change from Baseline in Body Weight(Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR)
- Number of Hypoglycemic Events(Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR)
- Number of Self-Reported Gastrointestinal (GI) Adverse Events(Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR)
- Percentage of Participants Achieving HbA1c <7%(Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR)
- Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L)(SoR (Week 0), EoR (Week 4))
研究者
研究点 (56)
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