NCT01110746已完成3 期
A Double-blind Study of the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
Biodel1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
研究概览
简要总结
The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
- •Current usage of subcutaneous insulin pump treatment with one of the following pumps:
- •Medtronic Paradigm®
- •ACCU-CHEK Spirit®
- •Age 18-75 years
- •HbA1c of 6.0 - 9.0% at screening visit.
- •Willingness to attend 9 clinic visits.
排除标准
- •Pregnancy or Lactation
- •Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
- •Congestive heart failure.
- •Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
- •Active coronary artery disease or heart procedure within the past 4 months.
- •Active foot ulceration.
- •Severe peripheral arterial disease.
- •Stroke within the past 6 months.
- •Active alcohol abuse, substance abuse, or severe mental illness.
- •Active cancer, except basal cell or squamous cell skin cancers.
- •Major surgical operation within 30 days prior to screening.
- •Seizure disorder (epilepsy).
- •Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- •Currently use of corticosteroids.
- •History of major non-compliance.
- •Use of an investigational drug within 30 days prior to screening.
- •Bleeding disorder, treatment with warfarin, or low platelet count.
- •Any insulin allergy
- •Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema.
- •History of gastroparesis.
研究组 & 干预措施
Formulation A
Experimental
Single Injection
干预措施: Viaject 7 (Drug)
Formulation B
Experimental
Single Injection
干预措施: LISPRO (Drug)
结局指标
主要结局
3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
时间窗: 3 hours
次要结局
- Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe).(72 hours)
研究者
研究点 (1)
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