Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 29
- 试验地点
- 11
- 主要终点
- Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide
研究概览
简要总结
The purpose of this study is to find out how effective and safe glipizide is for lowering blood sugar in people with pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Biopsy-proven PDAC
- •Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
- •Willing and able to comply with the requirements of the protocol
- •Willing to use their bluetooth-enabled wifi or cellular mobile device
- •Hemoglobin A1c (HbA1c) > 7%, or fructosamine > 287 mg/dL, or random glucose > 180 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is ≥154 mg/dL
- •Eastern Cooperative Oncology Group performance status ≤2
- •BMI <30 kg/m2
- •Age ≥18 years
- •Biopsy-proven PDAC
- •Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic pancreatic cancer)
- •Clinical diagnosis of diabetes mellitus
- •Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period from which data were recorded in the electronic medical record (in this retrospective study patients need not be under active care at the time the research is conducted)
- •At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, or glyburide) or metformin
- •Three-month baseline period before metformin or sulfonylurea initiation in which the participant does not receive either drug class or insulin
- •Body weight recorded within 3 months before start of metformin or a sulfonylurea
- •Age ≥18 years
- •Biopsy-proven PDAC
- •Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
- •Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period of data collection
- •Apparent current use based on chart review of metformin (but not sulfonylurea); sulfonylurea (but not metformin); or neither drug
排除标准
- •Use during the past month of any antidiabetic medication other than metformin at home (sporadic use [fewer than 1 of 7 days during the past month] is permitted)
- •Changes in metformin dose in the past month
- •History of sulfonylurea intolerance or allergy
- •History of severe hypoglycemia (hypoglycemia requiring emergency medical assistance, emergency room or urgent care visit, or hospital admission)
- •AST or ALT >3 x upper limit of normal
- •Glomerular filtration rate <30 mL/min/1.73m2
- •Daily chronic use of any dose of corticosteroids (as distinct from intermittent exposure to steroids as part of cyclic chemotherapy)
- •Inability to wear CGM
- •Greater than trace ascites documented on imaging or physical exam
- •Greater than trace ascites documented on imaging or physical exam
研究组 & 干预措施
Cohort 2a
Participants in this cohort will include people who have received various types of treatment for their hyperglycemia and pancreatic cancer. People's medical records will be reviewed to compare the effects of glipizide with the effects of other standard medications used to treat hyperglycemia.
Cohort 2b
Participants in this cohort will complete a questionnaire about their use of hyperglycemia medications. Participants from Cohort 2a will take part in this group.
Cohort 1
Participants in this cohort will receive glipizide for up to 4 months and participate in continuous glucose monitoring for as long as they are receiving the drug.
干预措施: Glipizide (Drug)
结局指标
主要结局
Change in mean interstitial glucose level for Cohort 1 participants before and after initiation of glipizide
时间窗: 48 hours after glipizide initiation
The mean value measured over a 48-h period before initiation of glipizide will be compared with the mean value measured over a 48-h period after glipizide initiation for participants in Cohort 1
次要结局
未报告次要终点