Protocol 2: Elucidation of Mechanisms Responsible for the Increase in EGP Following SGLT2 Inhibition: Decrease in Plasma Glucose Conc or Change in Islet Hormone (Glucagon/Insulin) Secretion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Plasma Glucose Concentration
研究概览
简要总结
In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP following SGLT2 inhibition.
详细描述
The inhibition of the renal (kidney) SGLT2 transporter has proven to be an effective therapeutic intervention to reduce plasma glucose levels (amount of glucose found in the liquid part of blood) and HbA1c.
In this study, the investigators hope to define the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration. The investigators will examine whether the signal for the increase in EGP (endogenous glucose production) caused by glucosuria (an excess of sugar in the urine, typically associated with diabetes) is mediated via the decrease in plasma glucose and insulin concentrations, or by the increase in plasma glucagon concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •T2DM subjects
- •18 - 70 yrs old
- •BMI = 25-45 kg/m2
- •Must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
- •HbA1c <10.0%
- •Stable body weight (± 3 lbs) over preceding 3 months
- •Do not participate in excessively heavy exercise
排除标准
- •Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
- •Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg
研究组 & 干预措施
Placebo
10 subjects will receive placebo
干预措施: Placebo (Drug)
Dapagliflozin
20 subjects will receive dapagliflozin 10mg
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Change in Plasma Glucose Concentration
时间窗: Baseline to 240-300 minutes
Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration
Change in Endogenous Glucose Production (EGP)
时间窗: Baseline to 240-300 minutes
The change in endogenous glucose production is measured from baseline until the last hour of the study
次要结局
- Change in Plasma Insulin During Measurement of EGP(Baseline to 240-300 minutes)
- Change in Glucagon During EGP Measurement(Baseline to 240-300 minutes)