CTRI/2022/07/044179已完成3 期
A Randomized, Double Blind, Active Controlled, Parallel Group, Multicentric, Phase-III clinical trial to compare the Efficacy, Safety and Tolerability of FDC of Dapagliflozin 10 mg plus Linagliptin 5mg tablets versus FDC of Dapagliflozin 10 mg plus Vildagliptin SR 100 mg Tablets in patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 17
- 主要终点
- Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16
研究概览
简要总结
A Randomized, Double Blind, Active Controlled, ParallelGroup, Multicentric, Phase-III clinical trial to compare the Efficacy, Safetyand Tolerability of FDC of Dapagliflozin 10 mg plus Linagliptin 5mg tabletsversus FDC of Dapagliflozin 10 mg plusVildagliptin SR 100 mg Tablets in patients with Type 2 Diabetes Mellitus.
In the current trial, reduction in glycemic parameters(HbA1c, FBG, PPBG) was found to be statistically significant with Dapagliflozin10 mg + Linagliptin 5 mg Tablets as compared to FDC of Dapagliflozin 10 mg +Vildagliptin SR 100 mg Tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged ≥18 to ≤65 years of age of both gender with diagnosis of Type 2 diabetes mellitus.
- •Inadequate glycemic control at screening defined as HbA1c levels of ≥8.0% to ≤ 11.0%.
- •Subjects who have received stable dose of metformin IR /ER > 1500 mg/day (> 1000mg/day for subjects not tolerating) as monotherapy for at least 8 weeks prior to screening
- •Subjects with BMI less than or equal to 45.0 kg/m2 at screening
- •Female subjects of childbearing potential using adequate contraception
- •Willingness to sign written informed consent document.
排除标准
- •1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breast feeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study 2.Patients with Fasting Plasma Glucose (FPG) > 270 mg/dL at screening (If FPG is > 270 mg/dL at screening, FPG will be repeated within 1 week.
- •If repeat FPG is > 270 mg/dL, patient will be excluded from the study).
- •3.Patients with Estimated glomerular filtration rate (eGFR) <60mL/min/1.73 m2 [using the Modification of Diet in Renal Disease(MDRD) equation] at screening.
- •4.Patients with clinically significant impaired hepatic function (SGOT &SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
- •5.Subjects with History of metabolic acidosis or diabetic ketoacidosis 6.Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- •7.Subjects with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic infection within 4 weeks prior to screening 8.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
- •9.Subjects with Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors orDPP4 inhibitors 10.Any other condition that in opinion of the investigator does not justify patient’s participation in study.
- •11.Participation in another clinical trial within past 30 days.
结局指标
主要结局
Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16
时间窗: Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16
次要结局
- Mean change in Postprandial Blood Glucose (PPBG) from baseline to Week 16(Mean change in Fasting Blood Glucose (FBG) from baseline to Week 16)
研究者
研究点 (17)
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