Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- postprandial glucose homeostasis
研究概览
简要总结
Dapagliflozin is a highly selective, reversible and potent inhibitor of the sodium-glucose-linked Transporter 2 (SGLT2), which was successfully investigated for its use as a treatment option in type 2 diabetes mellitus. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2 diabetic patients. Due to its mechanism-of action it seems likely that also type 1 diabetic patients will benefit from dapagliflozin. The present study is focused on the effects of dapagliflozin on fasting glucose homeostasis and postprandial glucose excursion in male type 1diabetic patients. Participants will subsequently receive 10 milligrams of dapagliflozin and placebo for 3 days (equals 2 x 30mg per cross-over period) in a double-blind, randomised, cross-over design. The effects will be measured via euglycemic hyperinsulinemic clamp studies (fasting glucose homeostasis) and euglycemic oral glucose tolerance clamp tests (postprandial glucose excursions).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (duration of disease at least 5 years)
- •C-peptide concentration < 0.2µg/l
- •aged 18 to 60 years
- •Body Mass Index 20 - 25 kg/m2
- •no measurable, clinically relevant ketonuria
排除标准
- •insufficient venous status on both forearms
- •renal and/or hepatic insufficiency (including microalbuminuria and/or albumin/creatinin-ratio)
- •history of cancer
- •intake of medication and/or substances capable to influence insulin sensitivity within the last 3 months prior to study inclusion
- •alcohol- and/or drug abuse, nicotine consumption > 5 cigarettes / 24h
- •brittle-diabetes
- •history of severe hypoglycemia, defined as the need for foreign assistance independent of actual blood glucose concentration measured
- •history or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the participant to give written informed consent, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
研究组 & 干预措施
dapagliflozin
10mg dapagliflozin per 24h for 3 days per cross-over phase (equals 2 x 30mg)
干预措施: Dapagliflozin (Drug)
placebo sugar pills
placebo tablet, 1 per 24h for 3 days in total per cross-over phase (equals 2 x 3 tablets)
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
postprandial glucose homeostasis
时间窗: study visit, immediatly
During euglycemic oral glucose tolerance clamp tests, postprandial glucose excursion will be determined and compared between dapagliflozin and placebo.
fasting glucose homeostasis
时间窗: study visit, immediatly
During hyperinsulinemic, euglycemic clamp studies, fasting glucose homeostasis will be determined for both, dapagliflozin and placebo.
次要结局
未报告次要终点
研究者
Markus Laimer
PD MD
Medical University Innsbruck