EUCTR2006-000247-26-GB进行中（未招募）不适用
A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients with Type 2 Diabetes Treated with Once-Daily Insulin Glargine - IDBA
Eli Lilly and Company Ltd0 个研究点目标入组 510 人开始时间: 2006年5月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 510
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
- •Patients are eligible to be included in the study only if they meet all of the following
- •criteria at screening or otherwise as described below:
- •[1] Are male or female who are 18 years of age or older,
- •[2] Have had type 2 diabetes mellitus, based on the disease diagnosis
- •criteria (Section 4.1.1), for at least 6 months’ duration at study entry,
- •[3] Have been treated with the following regimen:
- •one or more oral antihyperglycemic medications on a stable dose
- •for at least 6 weeks (3 months for thiazolidinediones [TZDs])
- •once-daily insulin glargine for at least 4 months
- •[4] Have HbA1c =7.5 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 except
- •cotinine will be repeated.
- •Retesting may occur as long as the screening period for the study is
- •still ongoing at the time of the retest.
- •Patients who were screened for this study prior to the approval of protocol amendment b and who failed to meet this inclusion criterion due to an HbA1c of > 9.5% may be rescreened if the screening HbA1c was also = 10.5%.
- •[5] If female, are not breastfeeding
- •If female and of childbearing potential (not surgically sterilized and
- •between menarche and 1 year postmenopause), 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] 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 4 weeks.
- •Retesting may occur as long as the screening period for the study is
- •still ongoing at the time of the retest.
- •[7] Are able to perform pulmonary function testing, according to
- •guidelines from the American Thoracic Society (ATS) (1995),
- •[8] Have PFTs graded as A,” B,” or C” in quality (see Section 6.3.3.1)
- •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 three acceptable FEV1,
- •FVC, and two acceptable DLCO maneuvers, two of which are
- •reproducible (within 0.20 L for FEV1 and FVC; and within
- •2.5 standard DLCO units for DLCO).
- •o If the patients are not able to meet the reproducibility criteria
- 另有 7 项未显示
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[11] Are investigative site personnel directly affiliated with the 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 completed or withdrawn from this study
- •or any study investigating any form of inhaled insulin and took one or
- •more doses of inhaled insulin, or have previously taken any form of
- •inhaled insulin,
- •[15] 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 the UK, patients who are on a TZD and glargine at study entry may be enrolled, if the patient is classified as NYHA I, and has been stable (from a cardiovascular perspective) while on this medication combination. In other
- •countries where the combination of the TZD and insulin is not
- •approved, patients taking any TZD at study entry will be excluded.
- •[16] Have had more than two episodes of severe hypoglycemia during the
- •6 months prior to study entry (see Section 5.9 for information about
- •severe hypoglycemia),
- •[17] Have had more than one hospitalization or emergency room visit due
- •to poor diabetic control during the 6 months prior to study entry,
- •[18] Have had a lower respiratory infection in the 3 months prior to
- •screening, evidenced by diagnosed pneumonia (on clinical or
- •radiologic grounds),
- •[19] 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] Have obvious clinical signs or symptoms of liver disease, acute or
- •chronic active hepatitis, or alanine aminotransaminase/serum glutamic
- •pyruvic transaminase (ALT/SGPT) greater than three times the upper
- •limit of the reference range,
- •[21] Have a history of renal transplantation, are currently receiving renal
- •dialysis, or have a serum creatinine >2.0 mg/dL (177 µmol/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 µmol/L]
- •for males or =1.4 mg/dL [123 µmol/L] for females),
- •[22] Have a history of angina, myocardial infarction, or Functional Capacity Class II,III/IV cardiac disease (patients taking a TZD), Functional
- •Capacity Class III/IV cardiac disease (patients not taking a TZD) (as defined by the New York
- •Heart Association [Attachment IDBA.5]) within the 6 months prior to
- •study entry.
- •[23] 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] Have a current or past history of lung cancer,
- •[25] Have a history of lung transplantation,
- •[26] Have a current diagnosis or past history of asthma, chronic obstructive
- 另有 1 项未显示
研究者
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