EUCTR2006-005383-51-ES进行中（未招募）1 期
A Phase 3, Open-Label, Crossover Study to Evaluate theEfficacy and Safety of Human Insulin Inhalation Powder(HIIP) Compared with Once-Daily Insulin Glargine inInsulin-Naïve Patients with Type 2 Diabetes Mellitus onOral Agents
illy S.A.0 个研究点目标入组 132 人开始时间: 2012年3月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- •[1] male or female patients who are 18 years of age or older,
- •[2] patients who have had type 2 diabetes mellitus for at least 6 months?
- •duration at study entry,
- •[3] patients who have been treated with one or more OAMs on a stable
- •dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
- •? have been on insulin for 30 days or less throughout life and have not
- •taken insulin within 6 months,
- •? are candidates for insulin therapy, in the opinion of the investigator.
- •[4] patients who have HbA1c ?8.0 and ?10.5% at screening,
- •? If the HbA1c criterion is not met at the first screening visit, the
- •patient may undergo retest of HbA1c once within a 3-month
- •period. If less than 1 month has passed since the initial screening,
- •only the HbA1c test will be repeated. If more than 1 month, but
- •less than 3 months have passed, the entire screening panel will be
- •repeated except cotinine.
- •? Retesting may occur as long as the screening period for the study is
- •still ongoing at the time of the retest.
- •[5] if female, patients must not be breastfeeding,
- •if female patients are of childbearing potential (not surgically sterilized
- •and between menarche and 1 year postmenopausal), they must
- •? test negative for pregnancy at the time of screening based on a
- •urine or serum test,
- •? intend not to become pregnant during the study,
- •? agree to use a reliable method of birth control (for example, use of
- •oral contraceptives or Norplant®; a reliable barrier method of birth
- •control [diaphragms with contraceptive jelly; cervical caps with
- •contraceptive jelly; condoms with contraceptive foam; intrauterine
- •devices]; partner with vasectomy) during the study.
- •[6] patients who are nonsmokers, have not smoked for at least 6 months
- •prior to entering the study, and agree not to smoke (cigars, cigarettes,
- •or pipes) or use smokeless tobacco for the duration of the study.
- •Serum cotinine level must be <20 ng/mL at screening,
- •? If the patient is a nonsmoker for a period of ?6 months, and the
- •serum cotinine level is ?20 and ?100 ng/mL, the patient may
- •undergo retesting of serum cotinine once within a 4-week period.
- •? Retesting may occur as long as the screening period for the study is
- •still ongoing at the time of the retest.
- •[7] patients who are able to perform pulmonary function testing, according
- •to guidelines from the American Thoracic Society (ATS) (ATS 1995),
- •[8] patients who have PFTs graded as ?A,? ?B,? or ?C? in quality and
- •satisfy all of the following criteria for PFTs:
- •? DLCO >70% of predicted,
- •? FEV1/FVC > lower limit of normal and FEV1 >70% predicted,
- •? patients should be able to perform at least 3 acceptable FEV1
- •and FVC maneuvers, and 2 acceptable DLCO maneuvers. For
- •each test, 2 of the maneuvers must be reproducible (within
- •0.20 L for FEV1 and FVC; and within 2.5 standard DLCO units
- •? If the patients are not able to meet the reproducibility
- •criteria for FEV1, FVC, or DLCO maneuvers, they may
- •return for retest within a 4-week period.
- 另有 9 项未显示
排除标准
- •[11] are investigative site personnel directly affiliated with this study and/or
- •their immediate families. Immediate family is defined as a spouse,
- •parent, child, or sibling, whether biological or legally adopted,
- •[12] are Lilly or Alkermes employees,
- •[13] have received treatment within the last 30 days with a drug that has not
- •received regulatory approval for any indication at the time of study
- •[14] patients who have previously received 1 or more doses of any form of
- •inhaled insulin, or have previously completed or discontinued from
- •this study,
- •[15] patients who are taking a TZD dose greater than what is indicated in
- •combination with insulin according to the TZD label in the respective
- •country (for example, in the United States, rosiglitazone greater than
- •4 mg daily or pioglitazone greater than 45 mg daily is not currently
- •indicated). In countries where the combination of the TZD and insulin
- •is not approved, patients taking any TZD at study entry will be
- •[16] patients who have had more than 2 episodes of severe hypoglycemia
- •during the 6 months prior to study entry (see Section 5.9 for
- •information about severe hypoglycemia),
- •[17] patients who have had more than 1 hospitalization or emergency room
- •visit due to poor diabetic control during the 6 months prior to study
- •[18] patients who have had pneumonia in the 3 months prior to screening,
- •on clinical or radiologic grounds,
- •[19] patients who have received systemic glucocorticoid therapy within the
- •3 months prior to study entry (topical preparations, nasal preparations,
- •intra-articular administration, as well as physiologic replacement for
- •Addison?s Disease and hypopituitarism are permitted),
- •[20] patients who have obvious clinical signs or symptoms of liver disease,
- •acute or chronic hepatitis, or alanine aminotransaminase/serum
- •glutamic pyruvic transaminase (ALT/SGPT) greater than 3 times the
- •upper limit of the reference range,
- •[21] patients who have a history of renal transplantation, are currently
- •receiving renal dialysis, or have a serum creatinine >2.0 mg/dL
- •(177 ?mol/L) if not on metformin; or if on metformin at study entry,
- •have a serum creatinine above what is contraindicated in the
- •metformin label in the respective country (for example, in the United
- •States, ?1.5 mg/dL [132 ?mol/L] for males or ?1.4 mg/dL
- •[123 ?mol/L] for females),
- •[22] patients who have a history of angina, myocardial infarction (MI), or
- •Functional Capacity Class III/IV cardiac disease (as defined by the
- •New York Heart Association [Protocol Attachment IDAZ.5]) within
- •the 6 months prior to study entry,
- •[23] patients who have an active or untreated malignancy, or have been in
- •remission from a clinically significant malignancy (other than basal
- •cell or squamous cell skin cancer, in situ carcinoma of the cervix, or in
- •situ prostate cancer) for less than 5 years,
- •[24] patients who have a current or past history of lung cancer,
- •[25] patients who have a history of lung transplantation,
- •[26] patients who have a current diagnosis or past history of asthma,
- •chronic obstructive pulmonary disease (COPD), cystic fibrosis,
- •bronchiectasis, alpha-1 antitrypsin deficiency, or other clinically
- 另有 6 项未显示
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