Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Blood glucose concentrations at pre-defined intervals
研究概览
简要总结
The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin, C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
- •Body mass index (BMI) 20 - 40 kg/m2
- •Age 18 - 70 years
- •Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
- •Glycated haemoglobin A1c (HbA1c) ≥ 6.0% and ≤ 7.9%
- •Haemoglobin above the lower limit of the normal range (i.e. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. >10mcg/L)
排除标准
- •Use of any medication that may influence gastrointestinal motor function, body weight or appetite
- •Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
- •History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
- •Other significant illness, including epilepsy, cardiovascular or respiratory disease
- •Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
- •Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal range))
- •Allergy to vildagliptin or any other 'gliptin'
- •Donation of blood within the previous 3 months
- •Participation in any other research studies within the previous 3 months
- •Females who are pre-menopausal
- •Inability to give informed consent
- •Vegetarians
研究组 & 干预措施
5 mg saxagliptin + 100 mg acarbose
Acute dosing:
5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal
干预措施: Saxagliptin (Drug)
100 mg acarbose
Acute dosing:
100 mg acarbose is given with a test meal
干预措施: Acarbose (Drug)
5 mg saxagliptin + 100 mg acarbose
Acute dosing:
5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal
干预措施: Acarbose (Drug)
5 mg saxagliptin
Acute dosing:
5 mg saxagliptin is given 60 min before a test meal,
干预措施: Saxagliptin (Drug)
结局指标
主要结局
Blood glucose concentrations at pre-defined intervals
时间窗: -60,-10,0,30,60,90,120,180min
次要结局
- Plasma concentrations of insulin at pre-defined intervals(-60,-10,0,30,60,90,120,180min)
- Plasma concentrations of C-peptide at pre-defined intervals(-60,-10,0,30,60,90,120,180min)
- Plasma concentrations of incretin hormones at pre-defined intervals(-60,-10,0,30,60,90,120,180min)
- Plasma concentrations of glucagon at pre-defined intervals(-60,-10,0,30,60,90,120,180min)
- half-emptying time (T50)(0-180min)
研究者
Zilin Sun
MD, PhD of Department of Endocrinology
Zhongda Hospital