NCT03495908已完成不适用
Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes
East Coast Institute for Research3 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2018年4月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.
研究概览
简要总结
The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years at time of study enrollment
- •Diagnosed with T2D for at least 6 months prior to screening
- •Screening visit A1C ≥ 7.0% and ≤ 12.5%
- •Prescribed a stable (less than 20% change in the past 30 days) of rapid acting U-100 insulin delivered via V-Go insulin delivery device
- •Ability to read and understand English
- •Willing to complete all study related activities
- •Willing and able to understand and sign a written ICF indicating that they agree to participate and have been informed of all pertinent aspects of the study
- •Must be willing to take and record 7 glucose measurements per time period (pre-morning meal (fasting), pre-midday meal, pre-evening meal, and 2-hours after the start of the morning, midday, and evening meals, and at bedtime) three times throughout the study (prior to Visit 2, 3, and 4).
- •Completed a 7-point glucose profile prior to Visit 2
- •Able (by insurance or financial means) to cover the initial investment and ongoing cost of the V-Go insulin delivery device, insulin (current rapid acting insulin or potential new regular human insulin), personal glucometer and supplies for the length of the study.
排除标准
- •Subject with confirmed Type 1 diabetes
- •More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry
- •History of hypoglycemia unawareness
- •Require supplemental insulin in addition to V-Go therapy
- •Woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study. Women of childbearing potential are defined as any female who has experienced menarche and who it NOT permanently sterile of postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without and alternative medical cause.
- •Woman who are lactating.
- •Use of any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- •A recipient of a solid organ transplant
- •Current use of U-100 RHI in V-Go within 90 days of screening
- •Current use of U-500 RHI in V-Go within 90 days of screening
- •Currently on dialysis
- •Medical or other problems which in the opinion of the investigator will render study participation unsafe.
结局指标
主要结局
Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.
时间窗: Baseline and Week 12
Per protocol population for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference.
次要结局
- Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.(Baseline and Week 12)
- Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment.(Baseline and Week 12)
- Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment.(Baseline and Week 12)
- Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.(Baseline and Week 12)
- Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups.(Baseline and Week 12)
- Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis.(Baseline and Week 12)
研究者
研究点 (3)
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