NCT00754624已完成2 期
A Four-year, Safety and Tolerability, Open-Label, "Follow on" Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 39
- 主要终点
- Annual Rate of Change in FEV1 From Baseline to End of Study
研究概览
简要总结
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
详细描述
This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, & 2 for 48 mo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous completion of PDC-INS-0008 or MKC-TI-005
- •Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial
- •Subjects must be able to understand English or have access to validated primary language trial documents
- •Written informed consent
排除标准
- •Drug or alcohol dependency
- •Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)
- •Known hypersensitivity to the trial drug or to drugs of similar chemical structures
- •Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)
- •Evidence of moderate or greater ketones in urine
- •Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization)
- •Women who are pregnant
- •Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation
研究组 & 干预措施
TI Inhalation Powder
Experimental
Technosphere® Insulin Inhalation Powder
干预措施: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler (Drug)
结局指标
主要结局
Annual Rate of Change in FEV1 From Baseline to End of Study
时间窗: Baseline to 48 months
次要结局
- Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)(Baseline to last study measurement on treatment (maximum of 48 months))
- Annual Rate of Change in FVC From Baseline to End of Study(Baseline to 48 months)
- Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)(Baseline to last measurement on study drug (maximum of 48 months)
- High Resolution Computerized Tomography Scans of the Chest(End of study)
- Annual Rate of Change in DLCo From Baseline to End of Study(Baseline to 48 months)
- Change in Weight in kg From Baseline to End of Study(Baseline to last measurement on study drug (maximum of 48 months))
研究者
研究点 (39)
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