Real-World Effectiveness, Safety, and Patient-Reported Outcomes of Tirzepatide in Adults With Type 2 Diabetes Mellitus, Obesity, or Prediabetes in Pakistan: A Multicentre, Prospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 9
- 主要终点
- Change in HbA1c (type 2 diabetes cohort)
研究概览
简要总结
This is a multicentre, prospective, observational study of the medicine tirzepatide as it is used in routine clinical care in Pakistan. Tirzepatide is already approved for type 2 diabetes and for obesity, but there is very little information on how it works for people in South Asia, and none from Pakistan specifically. This study aims to fill that gap.
The study will follow 330 adults who are starting tirzepatide as part of their normal treatment, across ten diabetes and endocrinology centres in Pakistan. Everyone taking part has obesity, and they are grouped into three cohorts based on their blood sugar status at the start: obesity without diabetes, prediabetes with obesity, and type 2 diabetes with obesity.
The study does not change anyone's treatment. The treating doctor decides whether to prescribe tirzepatide, at what dose, and for how long. The study simply observes and records what happens over 24 weeks, with assessments at the start, at Weeks 12 to 14, and at Weeks 24 to 26.
The main things measured are the change in blood sugar control (HbA1c) in the diabetes cohort, and the change in body weight in the obesity and prediabetes cohorts. The study also looks at changes in blood pressure, cholesterol, and other measures, how well people stay on treatment, any side effects, and how participants feel about their treatment and quality of life. The findings will help doctors understand how tirzepatide performs in real-world care in Pakistan and inform its use in similar populations.
详细描述
Tirzepatide's pivotal trials enrolled very few South Asian participants and no Pakistani sites, while Pakistan carries one of the world's highest diabetes burdens. This study provides real-world effectiveness, safety, and patient-reported outcome data from Pakistani routine care to address that gap.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult aged 18 years or older
- •Obesity (BMI ≥ 30) meeting one cohort definition
- •Baseline HbA1c available to confirm cohort
- •Initiating tirzepatide as part of routine clinical care, decided independently of the study
- •No prior lifetime use of tirzepatide
- •Washout of at least 8 weeks from any GLP-1 or dual GIP/GLP-1 receptor agonist, if previously used
- •Baseline retinal (eye) screening completed
- •Able and willing to provide written informed consent
排除标准
- •Type 1 or secondary diabetes
- •Any prior tirzepatide use
- •Proliferative diabetic retinopathy or clinically significant macular oedema
- •Pregnancy or breastfeeding
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- •Active malignancy, or a major cardiovascular event within the past 3 months
- •Inability to undergo retinal assessment
- •Mental incapacity or language barrier preventing informed consent
研究组 & 干预措施
Obesity without diabetes
Adults with obesity (BMI ≥ 30) and normoglycaemia (HbA1c < 5.7%), with no diabetes diagnosis, initiating tirzepatide in routine clinical care. Followed for weight and metabolic outcomes over 26 weeks.
Prediabetes with obesity
Adults with obesity (BMI ≥ 30) and prediabetes (HbA1c 5.7-6.4%), initiating tirzepatide in routine clinical care. Followed for weight and metabolic outcomes over 26 weeks.
Type 2 diabetes with obesity
Adults with obesity (BMI ≥ 30) and type 2 diabetes mellitus diagnosed at least 6 months prior, initiating tirzepatide in routine clinical care. Followed for change in glycaemic control (HbA1c) over 26 weeks.
结局指标
主要结局
Change in HbA1c (type 2 diabetes cohort)
时间窗: Baseline to Week 26
Mean change in glycated haemoglobin (HbA1c) from baseline to Week 24 in the type 2 diabetes with obesity cohort, analysed using a mixed model for repeated measures.
Percentage change in body weight (obesity and prediabetes cohorts)
时间窗: Baseline to Week 26
Mean percentage change in body weight from baseline to Week 26 in the combined obesity and prediabetes cohorts, analysed using a mixed model for repeated measures.
次要结局
- Change in BMI(Baseline to Week 26)
- Change in waist circumference(Baseline to Week 26)
- Change in blood pressure(Baseline to Week 26)
- Change in lipid profile(Baseline to Week 26)
- Treatment persistence(Baseline to Week 26)
研究者
Muhammad Daoud Butt
Dr
Universiti Sains Malaysia