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.

Pfizer Pharma GmbH0 个研究点目标入组 340 人开始时间: 2006年10月27日最近更新: 2012年4月3日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Pfizer Pharma GmbH
入组人数: 340

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
•1. Diagnosis: Subjects with type 1 diabetes mellitus, as defined by the American
•Diabetes Association (Diabetes Care 2005 28: S37-42), for more than one year.
•2. Subjects who have not participated in a prior inhaled insulin clinical trial.
•3. Age: = 18 years.
•4. Current Therapy: 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 (i.e., no change in the type(s) of insulin or in the schedule of injections; dose changes are acceptable).
•5. Screening (week-4) HbA1c between 5.5% and 9.0% inclusive.
•6. Fasting plasma C-peptide = 0.20 nmol/L.
•7. Body Mass Index = 30. (BMI = Weight[kg] ÷ {Height[m]}2
•8. Subjects must have documentation of an ophthalmologic exam within 1 year of
•screening demonstrating no active proliferative retinopathy requiring treatment during the study. Documentation must be obtained prior to randomization.
•9. Subjects must be able to demonstrate the ability to adequately perform spirometry
•10. Subjects willing to perform specified home blood glucose monitoring and otherwise to comply with study protocol requirements.
•11. The investigator will be responsible for obtaining written informed consent prior to the subject participating in the study.
•12. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Subjects presenting with any of the following will not be included in the trial:
•1. Pregnant or lactating females, or females planning to become pregnant during the
•study. Females of childbearing potential must have a negative pregnancy test at screening and be using a medically accepted contraception method such as systemic hormones (birth control pills, hormonal implant device), intra-uterine device, barrier
•method (diaphragm with intravaginal spermicide, cervical cap, male or female condom). Females who become pregnant or who are unable or unwilling to maintain
•adequate contraception for the duration of the study will be withdrawn from the study.
•2. Donation of blood or receipt of blood transfusion during the 12 weeks prior to the
•screening visit, for the duration of the study, or for 30 days after completion of the study.
•3. Use of any other investigational drug during the two months prior to screening and for the duration of the study.
•4. Subjects on insulin pump treatment as part of their MDI regime during the 2 months prior to screening.
•5. Subjects with brittle” diabetes or a predisposition to severe hypoglycemia — i.e., 2 or more severe hypoglycemic episodes within the past 6 months, or any hospitalization or emergency room visit due to poor diabetic control within the past 6
•months. Similarly, during the baseline run-in period, any subject with more than one
•severe hypoglycemic episode or any hospitalization or emergency room visit due to poor diabetic control will be excluded from randomization. Severe hypoglycemia is defined in section 8.13.2 (SAFETY REPORTING, Other Safety Parameters, Hypoglycemia).
•6. Pulmonary Conditions:
•FEV1, defined as FEV1 <70% of predicted.
•Significant pulmonary diseases including:
•History of poorly-controlled, unstable or severe asthma.
•Severe (GOLD stage III or IV) chronic obstructive pulmonary disease (COPD).
•Any other significant respiratory disease which in the opinion of the investigator would impair absorption of inhaled insulin.
•7. Any smoking within the last 6 months prior to the screening visit. Smoking is not
•permitted at any time during this study.
•8. Metabolic Conditions:
•a. Significant hypoglycemia risk e.g. several episodes of hypoglycemia unawareness within past 6 months, known adrenal insufficiency, symptomatic autonomic neuropathy.
•b. Current chronic inhaled or systemic corticosteroid treatment likely to be of metabolic effect (prednisone equivalent >2 mg/day); intercurrent treatment at a
•higher dose is allowed if treatment duration does not exceed 2 weeks.
•c. Patients with celiac disease
•9. Active Liver disease; ALT = 2.0 times the upper limit of normal reference range for
•the central lab at screening. Evidence within the preceding six months of hepatic dysfunction e.g., AST or ALT 2.0 times or more of the upper limit of normal or hepatic disease, e.g., hepatitis, jaundice, cirrhosis.
•10. Cardiovascular conditions:
•a. Significant cardiovascular dysfunction and/or history including hospitalization
•within the preceding six months, e.g., congestive heart failure or serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks or cerebrovascular accident.
•b. Poorly-controlled hypertension (systolic blood pressure >180 mmHg, diastolic
•blood pressure >110 mmHg) on two readings (sitting).
•c. Abnormal screening ECG:
•predominant rhythm other than normal sinus;
•A-V block greater than first degree;
•resting heart rate

研究者

发起方

Pfizer Pharma GmbH

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