NL-OMON30738尚未招募4 期
A 52-WEEK MULTICENTER, OPEN-LABEL, RANDOMIZED, PARALLEL, TWO - ARM STUDY COMPARING EXUBERA® (INHALED HUMAN INSULIN) VS. HUMALOG® (INSULIN LISPRO), BOTH IN COMBINATION WITH INSULIN GLARGINE IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS - Exist
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects with type 1 diabetes mellitus
- •2. Age: > 18 years
- •3. For the 2 months prior to screening, subjects must have been on a stable insulin regimen involving at least 3 injections daily of insulin or an insulin analogue
- •4. Screening (week-4) HbA1c between 5.5% and 9.0% inclusive
- •5. Body Mass Index * 30
- •6. The investigator will be responsible for obtaining written informed consent prior to the subject participating in the study
排除标准
- •1. Pregnant or lactating females, or females planning to become pregnant during the study
- •2. Subjects on insulin pump treatment as part of their MDI regime during the 2 months prior to screening
- •3. Subjects with *brittle* diabetes or a predisposition to severe hypoglycemia
- •4. Some pulmonary, cardiovascular, neurological, phychological and metabolic conditions (see page 17/18 of the protocol)
- •5. Concomitant therapy with systemic glucocorticoids
研究者
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