Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 569
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to evaluate the changes in the metabolomic parameters before and after Saxagliptin treatment in type 2 diabetic patients.
研究概览
简要总结
This study is an open-label, cohort study to evaluate the potential mechanisms of Saxagliptin in the treatment of patients with type 2 diabetes (T2DM) using a comprehensive metabolomic method, in combination with fingerprint analysis and target analysis. It is a sub-study of STUDY: D168L00008.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •All the subject Inclusion Criteria should be referred to STUDY: D168L
- •Provision of informed consent prior to any study specific procedures
- •Diagnosed with type 2 diabetes
- •Men or women who are 18 years of age.
- •Patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks.
- •HbA1c are between 7.5% and 11.0%
排除标准
- •All the subject Exclusion Criteria should be referred to STUDY: D168L
- •Pregnant or breastfeeding patients.
- •Insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes).
- •Previous treatment with any dipeptidyl peptidase-IV (DPP-IV) inhibitors or Glucagon-like peptide-1 (GLP-1) analogue.
- •History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD).
- •Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,local injected and topical use of glucocorticoids is allowed.
- •Treatment with strong cytochrome P450 inhibitors.
- •Gastrointestinal surgery that could impact the absorption of study drug.
- •Contraindications to therapy as outlined in the saxagliptin package insert.
- •Hypersensitivity to saxagliptin
- •Have a history of, or currently have, acute or chronic pancreatitis.
- •Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
- •Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study.
- •Fasting plasma glucose >15mmol/l.
研究组 & 干预措施
Saxagliptin
干预措施: Saxagliptin (Drug)
结局指标
主要结局
The primary objective of the study is to evaluate the changes in the metabolomic parameters before and after Saxagliptin treatment in type 2 diabetic patients.
时间窗: 24 weeks
The primary objective of the study is to compare the different metabolomic profiling at baseline (before treatment) and at the end of the study drug administration(24 weeks) using a Liquid Chromatography-Mass Spectrometry (LC-MS) analysis.
次要结局
未报告次要终点
研究者
Guang Ning
the vice-president of Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai Jiao Tong University School of Medicine