NCT07228195招募中4 期
SGLT2i Therapy in Islet Transplantation (SIT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time In Range (TIR) 70- 180 mg/dL
研究概览
简要总结
This pilot clinical trial is designed to gather preliminary data on the efficacy and safety of empagliflozin, a diabetes drug in the sodium-glucose cotransporter 2 inhibitor (SGLT2i) class, in islet autotransplant recipients who have partial islet function.
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
- 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
- •Age 18-70 years old;
- •>1 year after TPIAT date at enrollment;
- •Partial islet function defined as stimulated C-peptide ≥0.6 ng/mL at screening/baseline visit, AND either (1) on insulin at ≤0.25 unit/kg/day OR (2) not on insulin but HbA1c >6.5%;
- •Stable diabetes management defined by stable on pump or multiple daily injections (MDI) for at least 8 weeks and <25% change in insulin dosing over prior 8 weeks.
- •Willing to manage diabetes medication management/dose adjustments for the duration of the study with study team MD
- •Willing to wear continuous glucose monitor for diabetes management (currently standard of care for TPIAT diabetes)
- •Willing to record insulin doses for 14 day intervals x 3 study visits.
- •Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart
- •No prescribed medications other than insulin to treat diabetes in the past 4 weeks.
排除标准
- •HbA1c >9%; on any non-insulin antihyperglycemic medication;
- •History of diabetic ketoacidosis (DKA) in the past 1 year;
- •Unable to drink Boost HP due to true milk protein allergy;
- •Underweight (BMI <18.5 kg/m2) [contraindicated by possible weight loss with SGLT2 inhibitors];
- •Renal failure defined by glomerular filtration rate <30 mL/min/m2;
- •Recurrent dehydration necessitating ED/hospital visits; one time/ rare hospital visits due to intercurrent illness are not exclusionary but repeated dehydration from a chronic condition will be exclusionary.
- •Expected to need systemic corticosteroids at >25 mg/day hydrocortisone equivalent over the 6-month study interval;
- •Known allergy to empagliflozin;
- •Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding;
- •Unwillingness to consent or return for study visits;
- •Non-English speaking.
- •Any other medical contraindication to treatment or study participation in the opinion of the investigator that would impact either patient's safety or their ability to complete the study.
研究组 & 干预措施
Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months
Active Comparator
干预措施: Empagliflozin 10 MG Oral Tablet [Jardiance] (Drug)
Empagliflozin 25 mg x 6 months
Active Comparator
干预措施: Empagliflozin 25 MG Oral Tablet (Drug)
No Medication x 3 months, then 25 mg Empagliflozin x 3 months
No Intervention
结局指标
主要结局
Time In Range (TIR) 70- 180 mg/dL
时间窗: Month 3
the primary comparison is between three treatment arms (control, empagliflozin 10 mg, and empagliflozin 25 mg) at 3 months on treatment
次要结局
- Time in Tight Range (TITR) 70-140 mg/dL(Month 6)
- Time in hypoglycemia <70 mg/dL(Month 6)
- Time in hypoglycemia <54 mg/dL(Month 6)
- Time in hyperglycemia >180 mg/dL(Month 6)
- Area under the curve 2 hour glucose from MMTT(Month 6)
- Hemoglobin A1c level(Month 6)
- Proinsulin(Month 6)
- Proportion of patients with ketones >=1.5(Month 6)
- ED/ hospital visits for diabetic ketoacidosis (DKA)(Month 6)
- Occurrence of urinary or genital tract infection(Month 6)
- Weight change(Month 6)
- Diabetes distress(Month 6)
研究者
研究点 (1)
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