EUCTR2015-001334-21-SE进行中（未招募）1 期
Study of the Effect of Vildagliptin versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects with Type 2 Diabetes
und University0 个研究点开始时间: 2015年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written consent has been given.
- •2. Patients with type 2 diabetes treated with a stable dose of metformin
- •3. Age 20-70 years.
- •4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
- •5. Ability to complete the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
- •2.A history of any secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
- •3.Type 1 diabetes, positive GAD antibodies
- •4.eGFR <60 ml/min
- •5.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- •6.Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
- •7.Any history of acute pancreatitis
- •8.Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
- •9.Liver disease such as cirrhosis or chronic active hepatitis
- •10.History of coronary heart disease or heart failure class III or IV
- •11.Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
- •12.Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
- •13.Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
- •14.Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
研究者
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