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
- 发起方
- AstraZeneca
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
研究概览
简要总结
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.
详细描述
During the study, an AstraZeneca representative/delegate will have regular contacts with the study site, including visits to site for the site monitoring and source data verification activities. Electronic Case Report Forms (eCRF) will be used for data collection and query handling. The investigator will sign the completed electronic Case Report Forms. A copy of the completed electronic Case Report Forms will be archived at the study site. Authorized representatives of AstraZeneca or delegate, a regulatory authority, or an Ethics Committee may perform audits or inspections at the center's. Number and percentages of Incidence of adverse events will be presented, stratified by age/gender/baseline medications. Annualised event rate shall also be presented in addition to the incidence rate during the study. Mean change in HbA1C from baseline to 6 months for patients will be analysed using paired t test / Wilcoxon signed-rank test at 5% level of significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dapagliflozin and saxagliptin
Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally
干预措施: dapagliflozin and saxagliptin (Drug)
结局指标
主要结局
Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
时间窗: Baseline to End of Study (Week 26)
Adverse events (AEs) including serious adverse events (SAEs), AEs leading to discontinuation (DAE), and adverse events of special interest (volume depletion, renal events, major hypoglycemic events, fractures, urinary/genital tract infections diabetic ketoacidosis, amputations and hospitalization for heart failure)
Clinically Important or Significant Abnormalities in Safety Laboratory Values
时间窗: Enrolment (Week -1) to End of Study (Week 26)
Clinical laboratory results were presented separately for haematology, clinical chemistry, and urinalysis variables. The number of participants with clinically important (haematology and clinical chemistry) or clinically significant (urinalysis) abnormalities in safety laboratory values are presented.
Clinically Important Abnormalities in ECG Values
时间窗: Time Frame: Baseline to End of Study (Week 26)
The number of participants with clinically important abnormalities in ECG values are presented.
Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure)
时间窗: Enrolment (Week -1) to End of Study (Week 26)
The number of participants with clinically important abnormalities in vital signs (pulse and blood pressure).
Clinically Significant Abnormalities in Physical Examinations
时间窗: Enrolment (Week -1) to End of Study (Week 26)
The number of participants with clinically significant abnormalities in physical examinations.
次要结局
- Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline(Baseline to Week 24)
- Weight Change at Week 24 Compared to Baseline(Baseline to Week 24)
- Systolic Blood Pressure Change at Week 24 Compared to Baseline(Baseline to Week 24)
- Fasting Plasma Glucose Change at Week 24 Compared to Baseline(Baseline to Week 24)