CTRI/2023/01/048826已完成3 期
A randomized, multi-centric, comparative, parallel, open-label, active-controlled, Phase III trial study to demonstrate the non-inferiority of Trelagliptin 100mg once weekly to Vildagliptin 50 mg twice daily in the management of Type-2 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 10
- 主要终点
- Mean change in glycosylated haemoglobin (HbA1c) levels.
研究概览
简要总结
Trelagliptin is an oral long-acting dipeptidyl peptidaseâ€4 (DPPâ€4) inhibitor with onceâ€weekly dosing in type 2 Diabetes Mellitus (T2DM). This study is designed to evaluate the efficacy and safety of Trelagliptin 100 mg tablets with once-weekly dosing in Indian T2DM patients. The patients will be enrolled based on the inclusion and exclusion criteria. The eligible patients will be randomized in a 1:1 ratio to receive Trelagliptin 100 mg tablet once in a week or Vildagliptin 50 mg tablet twice daily. All patients will receive the study drugs as per randomization for the duration of 16 weeks. The non-inferiority of Trelagliptin 100 mg tablets will be evaluated with Vildagliptin 50 mg tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged ≥18 years.
- •Naïve patients diagnosed with Type 2 diabetes mellitus.
- •Patients with glycosylated hemoglobin (HbA1c) ranged in 6.5-10% (both inclusive) at screening.
- •Patients who are willing to participate voluntarily and provide written informed consent.
排除标准
- •Patients with known hypersensitivity to Trelagliptin, Vildagliptin or any of the ingredients of the formulation.
- •History of acute or chronic liver disease, and SGOT or SGPT > 2.5 times of reference range or total bilirubin > 1.5 times of reference range during the screening period.
- •Renal insufficiency, with eGFR <60 ml/min/1.73 m2 or serum creatinine above 1.5 times of reference range at screening visit.
- •Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma), or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy)
- •Active heart disease (including acute myocardial infarction, unstable angina), moderate to severe congestive heart failure
- •History of epilepsy, mental illness, major depression, or previous abnormal thyroid function and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease.
- •Female patients who are pregnant, lactating or not following adequate contraceptive measures.
- •Patients otherwise judged to be inappropriate for inclusion in the study by the investigator.
- •Patients with known history of pancreatitis.
结局指标
主要结局
Mean change in glycosylated haemoglobin (HbA1c) levels.
时间窗: Baseline and end of week 16
次要结局
- Mean change in fasting blood glucose(Baseline and end of week 6, 12, 16)
- Mean change in 2-hours postprandial glucose(Baseline and end of week 6, 12, 16)
- Mean change in fasting insulin(Baseline and end of week 16)
- Mean change in fasting glucagon level(Baseline and end of week 16)
- Mean change in C-peptide level(Baseline and end of week 16)
- Mean change in GLP-1 levels(Baseline and end of week 16)
- Number of patients reporting incidences of adverse events(Entire study period)
研究者
研究点 (10)
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