Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients With Diabetes Mellitus Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,409
- 试验地点
- 50
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
研究概览
简要总结
The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.
详细描述
The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM.
The study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC).
This multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female participants ≥ 18 years of age;
- •Has a diagnosis of type 2 diabetes mellitus (T2DM)
- •Participants with:
- •newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
- •inadequate glycemic control on previously prescribed any oral antidiabetic drug.
- •VIPIDIA® is prescribed according to the approved label for the Russian Federation.
- •The participant's physician decides to prescribe VIPIDIA®:
- •as monotherapy or
- •as a part of combination therapy.
- •The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.
排除标准
- •Contraindications of respective approved Russian summary of product characteristics (SmPC);
- •In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study;
- •Had used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of VIPIDIA® treatment.
- •Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
研究组 & 干预措施
Alogliptin Benzoate
Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
干预措施: Alogliptin Benzoate (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
时间窗: Baseline and Month 6
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics(Baseline and Month 6)
- Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6(Baseline and Month 6)
- Change From Baseline in HbA1c Level Over Time(Baseline, Months 3 and 6)
- Percentage of Participants With Marked Hyperglycemia at Month 3(Month 3)
- Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time(Baseline, Months 3 and 6)
- Change From Baseline in Weight Over Time(Baseline, Months 3 and 6)
- Change From Baseline in Postprandial Glycemia Over Time(Baseline, Months 3 and 6)
- Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time(Baseline, Months 3 and 6)
- Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6(Baseline and Month 6)
- Percentage of Participants Who Used Healthcare Resources(Baseline up to Month 6)