Empagliflozin for the Treatment of Postprandial Hypoglycemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in Quality of life (mental health; as assessed by the SF-36 mental health component score; MCS)
研究概览
简要总结
This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.
详细描述
Postprandial hypoglycemia is a debilitating medical complication after bariatric surgery for which no approved pharmacological treatment exists. The prevalence of hypoglycemia in bariatric patients ranges from 0.5 % severe episodes up to 56 % and its symptoms range from asymptomatic to deleterious. This hypoglycemic condition is characterized by a rapid increase of plasma glucose after carbohydrate ingestion followed by an exaggerated hyperinsulinemic response. Hypoglycemia itself may lead to increased hunger, carbohydrate ingestion and following weight regain.
In a placebo-controlled, randomized, double-blind, crossover study, the SGLT2-inhibitor empagliflozin statistically significantly reduced the number of symptomatic hypoglycemia (2 vs. 7 symptomatic hypoglycemic episodes; p=0.013) compared to placebo after a mixed meal test in 12 patients after Roux-en-Y gastric bypass. Empagliflozin reduced the postprandial rise in glycemia and decreased subsequent insulin secretion, underlining the postulated mechanism of action.
This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.
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
- Double (Participant, Investigator)
盲法说明
Both subjects and investigators will be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega- loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. < 3.0 mmol/l and at least 5 hypoglycemic episodes per week despite dietary modification
- •For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study
- •Informed Consent as documented by signature
排除标准
- •Any type of diabetes mellitus according to ADA criteria
- •Intolerance to the study drug
- •Signs of current infection
- •Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (all remaining drugs have to be discontinued four half-life times before screening phase)
- •Neutropenia (leukocyte count < 1.5 × 109/L or absolute neutrophil count (ANC) < 0.5 × 109/L)
- •Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females)
- •Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, AST/ALT > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN)
- •Uncontrolled congestive heart failure
- •Uncontrolled malignant disease
- •Currently pregnant or breastfeeding
- •Known or suspected non-compliance, drug or alcohol abuse
- •Meeting the criteria for vulnerability (e.g. participants incapable of judgment or participants under tutelage)
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Participation in another clinical trial using investigational drugs in the last 30 days or planned participation in the next 60 days
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Empagliflozin
Standard dose of empagliflozin (Jardiance®; Boehringer Ingelheim GmbH), i. e. 10 mg. Empagliflozin is an orally available inhibitor of SGLT2 and approved for the treatment of type 2 diabetes mellitus and will be given per os once daily in the morning for 28 days.
干预措施: Empagliflozin (Jardiance®; (Drug)
Placebo
Placebo provided by Boehringer Ingelheim Switzerland. Per os once daily in the morning for 28 days.
干预措施: Placebo Control Intervention (Other)
结局指标
主要结局
Change in Quality of life (mental health; as assessed by the SF-36 mental health component score; MCS)
时间窗: at baseline, at day 29 and at day 60 (+/- 10 days) after baseline
Change in Quality of life (mental health; as assessed by the SF-36 mental health component. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Change in Quality of life (physical health; as assessed by the SF-36 mental physical component score; PCS)
时间窗: at baseline, at day 29 and at day 60 (+/- 10 days) after baseline
Change in Quality of life (physical health; as assessed by the SF-36 mental physical component score; PCS). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Hypoglycemic events defined as glucose values below 3.0 mmol/l
时间窗: at 28 days after randomization
Hypoglycemic events defined as glucose values below 3.0 mmol/l
次要结局
- Fear of hypoglycemia (measured on a scale of 0 to 10)(at 28 days after randomization)
- Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L(at 28 days after randomization)
- Postprandial Symptoms of hypoglycemia defined as acute onset of typical symptoms according to Edinburgh Hypoglycemia Scale along with a decreasing blood glucose level.(at 28 days after randomization)
- Time below range (TBR): % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)(at 28 days after randomization)
- Hypoglycemia unawareness (measured by modified Clarke Score)(at 28 days after randomization)
- Pattern of sensor glucose(at 28 days after randomization)
- Number of Serious adverse events(up to 60 days after randomization)
- Glycemic variability(at 28 days after randomization)
- Mean amplitude of sensor glucose excursions (MAGE)(at 28 days after randomization)
- Total number of adverse events(up to 60 days after randomization)