A Clinical Evaluation of Early Initiation of Oral Semaglutide as a Monotherapy or in Combination with Other Oral-Antidiabetic drugs in Indian Adults with Type 2 Diabetes: A Prospective Multicentric Non-interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 518
- 试验地点
- 20
- 主要终点
- Change in HbA1c (%) from baseline to
研究概览
简要总结
Type 2 diabetes (T2D) is a growing global health challenge, with India bearing a significant burden due to unique genetic, lifestyle, and socio-economic factors. Despite the availability of multiple oral antidiabetic drugs (OADs), achieving sustained glycemic control remains difficult due to side effects, patient non-adherence, and secondary OAD failure. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), is the first such agent available in oral form. Global studies, including the PIONEER trial program, have demonstrated its efficacy in improving HbA1c and reducing weight across different stages of T2D management. This prospective, multicentric, non-interventional study aims to evaluate the real-world clinical outcomes of early initiation of oral Semaglutide as monotherapy or in combination with other OADs in Indian adults with T2D. The findings may offer valuable insights into its effectiveness, tolerability, and potential for improving T2D outcomes in the Indian population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than or equal to 18 years (male and female)
- •Diagnosed with T2D within the last one year HbA1c level: 7.0 percentage to 9.5 percentage (both inclusive)
- •Drug-naive or on oral anti-diabetic medications within the last one year
- •Drug naive for GLP 1 agonists.
排除标准
- •Type 1 Diabetes Mellitus (T1DM)
- •Gestational Diabetes Mellitus (GDM)
- •Maturity Onset Diabetes of the Young (MODY)
- •Current ongoing steroid therapy
- •History of pancreatitis
- •Known Cup-to-disc ratio less than 0.2
- •History of Proliferative retinopathy or maculopathy requiring acute treatment (verified within 90 days prior to screening)
- •Osmotic symptoms
- •Personal or family history of medullary thyroid carcinoma (MTC) or MEN 2
- •eGFR less than 15 mL per min per 1.73 m² within the last one year
- •History of heart failure (New York Heart Association class IV)
- •History of Gallstones
- •History of malignant neoplasms within the last 5 years
- •Pregnant or planning pregnancy up to 9 months after enrollment
- •Already on insulin therapy or requires initiation of insulin therapy
- •Known hypersensitivity to OS or OADs or other GLP-1 analogues.
结局指标
主要结局
Change in HbA1c (%) from baseline to
时间窗: 26 weeks.
week 26.
时间窗: 26 weeks.
次要结局
- Change in Fasting Plasma Glucose-(FPG (mg/dL),Post Prandial Plasma Glucose- PPPG (mg/dL),)
- The study will evaluate the percentage of patients achieving(more than 1% HbA1c reduction with more than 3% or more than 5% weight loss, both with)
- The proportion of patients discontinuing OS(due to Gastrointestinal (GI) related AEs, treatment emergent)
- LFTs (AST (IU/L), ALT (IU/L), and(Serum bilirubin (mg/dl)) and STOP-Bang Score from baseline)
研究者
Dr Krishna G Seshadri
Apollo Speciality Hospitals