CTRI/2021/02/031471已完成4 期
A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- • Safety laboratory values
研究概览
简要总结
This study is designed togenerate local Indian safety evidence for Dapa/Saxa 10 mg/5 mg FDC as per localhealth regulatory request. The study objectives are to describe the adverseevents profile and efficacy of Dapa/Saxa fixed dose combinations in Indian T2DMpatients. Both dapagliflozin and saxagliptin are approved in India for clinicaluse as individual therapy for managing T2DM patients. This study is to providesafety data when both molecules are administered as FDC formulation. This is asingle arm study and no control group is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure.
- •Male and female patients aged > 18 and above
- •Documented history of type 2 diabetes mellitus with HbA1c level >7.0% and ≤ 10% at screening visit
- •Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months
- •Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy.
- •In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed.
- •Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
排除标准
- •Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
- •Active participation in another clinical study with IP and/or investigational device
- •For women only.
- •currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- •Type 1 diabetes mellitus.
- •Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
- •Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI formula, or end-stage renal disease (ESRD) or ‘Unstable or rapidly progressing renal disease
- •Patients with severe hepatic impairment (Child-Pugh class C)
- •History of pancreatitis or pancreatic surgery 9.Patients with a history of any malignancy
- •Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator: • Myocardial infarction. • Cardiac surgery or revascularization (CABG/PTCA). • Unstable angina. • Transient ischemic attack (TIA) or significant cerebrovascular disease. • Unstable or previously undiagnosed arrhythmia.
- •History of heart failure
- •Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg at any visit up to randomisation
- •History of diabetic ketoacidosis
- •Any acute/chronic systemic infections
- •Recurrent urogenital infections
- •Patients at risk for volume depletion as judged by the investigator
- •Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance.
结局指标
主要结局
• Safety laboratory values
时间窗: 24 weeks
Adverse Events (AEs) including Serious adverse events (SAEs), AEs leading to discontinuation (DAE) and adverse events of special interest (volume depletion, renal events, major hypoglycaemic events, fractures, urinary/genital tract infections, diabetic ketoacidosis, amputations and hospitalization for heart failure)
时间窗: 24 weeks
• Vital Signs (pulse and BP)
时间窗: 24 weeks
• Physical examination
时间窗: 24 weeks
• Electrocardiogram (ECG)
时间窗: 24 weeks
次要结局
- HbA1c change at week 24 compared to baseline.(Weight change at week 24 compared to baseline.)
研究者
研究点 (9)
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