Study of the Effect of Vildagliptin Versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Glucagon Response to Meal
研究概览
简要总结
The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis.
详细描述
The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis. Subjects will therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks followed by a meal test in which glucagon levels will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent has been given.
- •Patients with type 2 diabetes treated with a stable dose of metformin during the last three months
- •Age 20-70 years.
- •HbA1c 6.5-8.5% (48-67 mmol/mol) at visit
- •Ability to complete the study
排除标准
- •Use of other glucose-lowering therapy than metformin within three months prior to visit
- •A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- •Type 1 diabetes, positive GAD antibodies
- •Estimated glomerular filtration rate <60 ml/min
- •Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- •Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
- •Any history of acute pancreatitis
- •Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
- •Liver disease such as cirrhosis or chronic active hepatitis
- •History of coronary heart disease or heart failure class III or IV
- •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.
- •Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit
- •Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
- •Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
研究组 & 干预措施
Vildagliptin first
Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks
干预措施: Dapagliflozin (Drug)
Vildagliptin first
Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks
干预措施: Vildagliptin (Drug)
Dapagliflozin first
Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks
干预措施: Vildagliptin (Drug)
Dapagliflozin first
Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Glucagon Response to Meal
时间窗: 240 min
Area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150,180 and 240 minutes post-dose)
次要结局
- Incretin Hormones(240min)