Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Postprandial glucose
研究概览
简要总结
Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
详细描述
The study is a single-center study with a cross-over design to examine glycemia, incretin hormones and islet hormones over a 24h study period with standardized breakfast, lunch and dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of inclusion
- •Ongoing treatment with life style adjustment including diet and exercise regimen together with metformin as oral antidiabetic . Metformin therapy should be stable the last three months
- •Age 40-75 years
- •HbA1c 52-80 mmol/mol (inclusive)
- •BMI: 20-40 kg/m2
- •Written informed consent has been given
- •Capability and willingness to participate in the whole study
排除标准
- •• Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference range
- •Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
- •Proliferative diabetic retinopathy
- •Treatment with any glucose-lowering medication except metformin
- •Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
- •Symptomatic heart failure (NYHA class II-III)
- •Previous surgery on the gastrointestinal tract
- •Larger surgical intervention during the last 12 weeks
- •Female subject who are pregnant or breast feeding
- •Women of child bearing potential not using a highly effective method of birth control
- •Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
- •Hypersensitivity to the active substances of to any of the excipients
- •Participation in another study the last 4 weeks
- •Paracetamol intolerance
研究组 & 干预措施
Saxagliptin
Ssaxagliptin is given before breakfast
干预措施: Saxagliptin (Drug)
´Sitagliptin
Sitagliptin is given before breakfast
干预措施: Sitagliptin (Drug)
Vildagliptin
Vildagliptin is given before breakfast
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Postprandial glucose
时间窗: 180 min
The area under the 180 min curves for plasma glucose after each meal
次要结局
- Postprandial insulin and glucagon(180 min)
- Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)(180 min)