A Randomized, Non-inferiority, Open-label Clinical Trial to Evaluate the Safety and Efficacy of GAcarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes in Chinese
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention
研究概览
简要总结
To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before and after the interventions.
详细描述
Participants coming on study will be assigned to two groups：Acarbose+Saxagliptin and Metformin+Saxagliptin. It may take 1 weeks to be stabilize to a standardized dose, and then the investigators will follow-up the patients for 3 months.During the period,patients will be asked to come back to the investigators center to receive the related examination every month. The investigators will detect HbA1c，fasting and postprandial C-peptide before and after the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 2 diabetes mellitus（course of disease less than one year） who has not receive drug treatment.
- •T2DM patients who has not receive drug treatment for three months at least.
- •HbA1c for 7.5-10%.
排除标准
- •New or worsening signs or symptoms of coronary heart disease
- •Medical history of active liver disease and kidney disease
- •Poorly controlled hypertension（systolic blood pressure>160mmHg or diastolic blood pressure>95mmHg）
- •A clinically important hematological disorder
- •A history of intolerance or hypersensitivity or any contraindication to study medications (including saxagliptin, metformin, acarbose)
- •Is pregnant or breast feeding or is expecting to conceive or donate eggs
- •A medical history of drug abuse
- •Can not be followed -up on time
- •Endocrinological diseases（eg： hyperthyroidism、hypothyroidisn and cushing syndrom）
- •Gastrointestinal diseases
- •Mental disorser
- •Hypoxic disease
研究组 & 干预措施
metformin+Saxagliptin
metformin 0.5g tablet Saxagliptin 5mg tablet metformin 0.5g three times a day for three months Saxagliptin 5mg one time a day for three months
干预措施: Metformin (Drug)
metformin+Saxagliptin
metformin 0.5g tablet Saxagliptin 5mg tablet metformin 0.5g three times a day for three months Saxagliptin 5mg one time a day for three months
干预措施: Saxagliptin (Drug)
acarbose+Saxagliptin
acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months
干预措施: Acarbose (Drug)
acarbose+Saxagliptin
acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months
干预措施: Saxagliptin (Drug)
结局指标
主要结局
redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention
时间窗: baseline(0 week), week twelve
HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland).
次要结局
- Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study(baseline(0 week), week twelve)
- Difference of Homeostasis model assessment of insulin resistance (HOMA-IR) and Homeostasis model assessment beta cell function index (HOMA-β) between two groups after three months intervention(baseline(0 week), week twelve)
研究者
liao sun
principal investigator
Fifth Affiliated Hospital, Sun Yat-Sen University