A Prospective, Open-Label, Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes Following SYMLIN Introduction Into the Marketplace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,297
- 试验地点
- 1
- 主要终点
- Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
研究概览
简要总结
This is an open label, observational study designed to collect data that characterize the use of SYMLIN following the introduction of the medication into the marketplace. Health care providers and subjects selected for study participation are intended to be representative of those providers prescribing, and subjects receiving, SYMLIN therapy.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •The following inclusion criteria are consistent with information in the SYMLIN package insert and apply to insulin using patients with type 2 or type 1 diabetes who:
- •Have failed to achieve the desired or optimal level of glycemic control despite utilizing appropriate, individualized insulin regimens
- •Have A1C <=9.0% within 3 months of study enrollment
- •Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN
排除标准
- •The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:
- •Are poorly compliant with their current insulin regimen, as defined by their HCP
- •Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP
- •Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months
- •Have hypoglycemia unawareness
- •Have a confirmed diagnosis of gastroparesis
- •Require the use of drugs that stimulate gastrointestinal motility
- •Are female and pregnant or lactating and for whom the HCP determines the potential benefit does not justify the potential risk to the fetus or infant
- •Have been treated with SYMLIN within 3 months prior to study start
研究组 & 干预措施
Type 1
Patients with type 1 diabetes
干预措施: pramlintide acetate (Drug)
Type 2
Patients with type 2 diabetes
干预措施: pramlintide acetate (Drug)
结局指标
主要结局
Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
时间窗: 0-3 months
The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment. PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period
时间窗: 0-3 months
PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment
次要结局
- The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period(>3-6 months)
- Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period(0-3 months)
- Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period(>3-6 months)
- The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period(>3-6 months)
- The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period(0-3 months)
- Change in HbA1c From Baseline at Month 3(3 months)
- Change in Body Weight From Baseline at Month 3(3 months)
- Change in HbA1c From Baseline at Month 6(6 months)
- Change in Body Weight From Baseline at Month 6(6 months)
- Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period(>3-6 months)