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临床试验/CTRI/2018/09/015693
CTRI/2018/09/015693尚未招募Unknown

Real world experience of Glycomet GP (Glimepiride/Metformin) in management of Type 2 Diabetes mellitus in Indian Setting (REAL GGP)

USV Private Limited50 个研究点 分布在 1 个国家目标入组 8,500 人开始时间: 2018年12月9日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
8,500
试验地点
50
主要终点
Percentage of patients in various age group receiving Glycomet GP (Glimepiride/Metformin)

研究概览

简要总结

The objective of the study is to investigate real-world treatmentpatterns for use of Glycomet GP (Glimepiride/Metformin) and concomitantmedications in Indian patients with type 2 diabetes mellitus treated within theprimary care physicians and specialist care settings.

The real world experience study will be conducted in Indianhealth care centers having medical records of adult patients with type 2diabetes mellitus who had received treatment with Glycomet GP(Glimepiride/Metformin) .

Data related todemographic characteristics, efficacy, and safety parameters will be collectedfrom medical records authenticated by physicians during routine care.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Both Male and Female patients of age 18 years or older Patients who have received any strength of Glycomet GP (Glimepiride/Metformin) for the treatment of type 2 diabetes mellitus Treating physician had to agree to provide information regarding the participants treatment Patients whose medical records contains a minimum core data set; core data defined as: age, gender, duration of diabetes/ age at diagnosis, all glucose-lowering medications (branded and generic names, dosage and dosing frequency).

排除标准

  • Patients with Type 1 diabetes mellitus Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related) Female patients with gestational diabetes during pregnancy.

结局指标

主要结局

Percentage of patients in various age group receiving Glycomet GP (Glimepiride/Metformin)

时间窗: retrospective data

Number & percentage of Participants with Concomitant Conditions

时间窗: retrospective data

Number & percentage of Participants with Concomitant Therapies

时间窗: retrospective data

Duration of diabetes of participants received Glycomet GP (Glimepiride/Metformin)

时间窗: retrospective data

Dosage patterns of Glycomet GP (Glimepiride/Metformin) received by the participants

时间窗: retrospective data

次要结局

未报告次要终点

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (50)

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