Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.
研究概览
简要总结
The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 1 year
- •The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed.
- •Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion (CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
排除标准
- •Chronic oral steroid use
- •The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of sensors or the completion of any aspect of the protocol.
- •Known clinical history of celiac disease or inflammatory bowel disease. 4) Participants will have a negative anti-endomysial antibody or anti-tissue transglutaminase antibody within one year of enrollment.
- •Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7) Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
- •Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10 microunits per litter
研究组 & 干预措施
Humalog U-100 Insulin
干预措施: Humalog U-100 (Drug)
LINjeta U-100
干预措施: LINjeta U-100 Insulin (Drug)
结局指标
主要结局
The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.
时间窗: 2 weeks
The primary endpoint for this second phase is the 3 hour area under the curve from baseline following a standardized breakfast meal in the outpatient setting.
时间窗: 2 weeks
The primary endpoint for this third phase is daytime (6 am to midnight) average glucose values.is percent of CGMS glucose values in range (70-180 mg/dL) for the third week fo sensor data in each group.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Bruce A. Buckingham
Principle Investigator
Stanford University