A real-world prospective, multicenter, observational comparative study for Clinical Evaluation of Triple Combination Therapy (FDC Dapagliflozin, Metformin and Vildagliptin SR) versus Dual Drug Combinations (FDC Dapagliflozin plus Metformin and FDC Dapagliflozin plus Vildagliptin SR) and assess their effectiveness and safety in Type 2 Diabetes Management.

USV Private Limited5 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年5月5日最近更新: 2025年4月21日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: USV Private Limited
入组人数: 100
试验地点: 5
主要终点: changes in demographic characteristics, clinical parameters and treatment pattern

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a real-world prospective, multicenter, observational study for Clinical Evaluation of Triple Combination Therapy (FDC Dapagliflozin, Metformin and Vildagliptin SR) versus Dual Drug Combinations (FDC Dapagliflozin, Metformin and FDC Dapagliflozin, Vildagliptin SR) and a Comparative Study on Effectiveness and Safety in Type 2 Diabetes Management.

Data related to demographic characteristics, duration of disease, co-morbidities, concomitant medications, lab results and dosage pattern will be collected from medical records authenticated by physicians/cardiologists during routine care.

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, fixed
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•1.Subject willing to provide written informed consent.
•2.Subject having documented history of diabetes mellitus greater than or equal to 12 months 3.Subjects receiving 2 or more Oral anti-hyperglycaemic medications (OAMs) at stable doses for 12 weeks prior to screening, with metformin greater than or equal 500 mg per day or dapagliflozin ( greater than or equal 5 mg/day) or vildagliptin (greater than or equal 100 mg/day) 4.Glycated haemoglobin (HbA1c) between 8.0% and 10.5%.
•5.Subjects with body mass index (BMI) Greater than 18 kg/m² and less than 40 kg/m² at screening 6.Ability and willingness to administer study medication as prescribed by the study investigator 7.As determined by the investigator, the subject should be capable and willing to do the following: a.Perform self-monitored blood glucose (SMBG) at least once weekly and at the occurrence of hypoglycaemia symptoms b.Complete subject diaries as instructed c.Be receptive to diabetes education.

排除标准

•1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation 2.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with the test product to be used 3.Female subject who is pregnant or lactating 4.Subjects with a diagnosis of type 1 diabetes, gestational diabetes mellitus 5.Subject with abnormal eGFR (less than 30 mL per min or 1.73 m2).
•6.Subjects with any one of the following comorbid conditions – physical or mental retardation, or malignancy 7.Participants with a recent history (within the previous 6 months) or current history of drug abuse or alcohol abuse 8.Not eligible to participate in this trial based on investigator opinion 9.Trial related conditions a.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent b.Suspected inability or unwillingness to comply with the study procedures.

结局指标

主要结局

changes in demographic characteristics, clinical parameters and treatment pattern

时间窗: From baseline to end of study

次要结局

evaluates the safety of patients(Safety will be evaluated at various time points of the study at 3 months & 6 months)

研究者

发起方

USV Private Limited

申办方类型

Pharmaceutical industry-Indian

研究点 (5)

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