NCT01109316已完成3 期
An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
研究概览
简要总结
This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of pump reservoir in-use. The study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months.
- •Treated with continuous subcutaneous insulin infusion therapy for the previous 6 months.
- •Mean total daily insulin dose for 3 days prior to screening equal to or less than 46 units/day using a 300-unit reservoir or less than or equal to 26 units/day using a 180 unit reservoir.
- •Baseline body mass index (BMI) less than or equal to 35.0 kg/m^
- •Baseline glycosylated hemoglobin (HbA1c) 5% to 9%.
排除标准
- •Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter [mg/dL]).
- •Legal blindness.
- •Have had any episode of hypoglycemic coma, seizures, or disorientation in the 12 months prior to screening.
- •Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose (BG) less than 45 mg/dL) in the 12 months prior to screening.
- •Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
- •Have had a pump-related infusion site abscess in the 12 months prior to screening.
- •Have had multiple, clinically significant occlusions as judged by the investigator.
- •Have had any infection with staphylococcus aureus in the past 5 years.
- •Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
- •Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
- •Have had a blood transfusion or severe blood loss within 3 months prior to screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular and inhaled prescriptions), or have received such therapy within the 4 weeks immediately preceding screening.
- •Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night), in the investigator's opinion.
- •Have known hypersensitivity or allergy to any of the study insulins or their excipients.
- •Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have previously completed or withdrawn from this study after having signed the informed consent document (ICD).
- •Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
研究组 & 干预措施
Insulin Lispro 2 Day
Active Comparator
干预措施: Insulin lispro 2 day reservoir in-use (Drug)
Insulin Lispro 6 Day
Experimental
干预措施: Insulin lispro 6 day reservoir in-use (Drug)
Insulin Aspart 6 Day
Active Comparator
干预措施: Insulin aspart 6 day reservoir in-use (Drug)
结局指标
主要结局
Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
时间窗: 8 weeks of each treatment
次要结局
- Mean SMBG(8 weeks for each treatment)
- Mean Daily Insulin Dose (Total, Basal, and Bolus)(8 weeks for each treatment)
- Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values(Baseline, 8 weeks for each treatment)
- Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%(8 weeks for each treatment)
- Percentage of Participants With Hyperglycemia(8 weeks for each treatment)
- Hyperglycemic Episode Rate Per 30 Days(8 weeks for each treatment)
- Hypoglycemia Episode Rate Per 30 Days(8 weeks for each treatment)
- Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure(Baseline, 8 weeks for each treatment)
- Percentage of Participants With Pump Complications(8 weeks for each treatment)
- Pump Complication Rate Per 30 Days(8 weeks for each treatment)
- Percentage of Participants With Hypoglycemia(8 weeks for each treatment)
- Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight(Baseline, 8 weeks for each treatment)
研究者
研究点 (1)
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