EUCTR2006-002999-17-BE进行中（未招募）不适用
A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naïve Patientswith Type 2 Diabetes Mellitus - IDAY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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 indicated below:
- •[1] male or female patients who are 18 years of age or older,
- •[2] patients who 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] patients who have been treated with the following regimen:
- •one or more oral antihyperglycemic medications on a stable dose for at
- •least 6 weeks (12 weeks for TZDs),
- •have been on insulin for 14 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 >7.0% and =10.5% at screening:
- •[5] female patients who are not breastfeeding and if female patients are of childbearing potential they must
- •test negative for pregnancy at the time of screening
- •intend not to become pregnant during the study,
- •agree to use a reliable method of birth control during the study.
- •[6] patients who are nonsmokers, have not smoked for >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.
- •[7] patients who are able to perform pulmonary function testing, according
- •to guidelines from the American Thoracic Society (ATS) (1995),
- •[8] patients who have PFTs graded as A,” B,” or C” in quality and satisfy all of the following criteria for pulmonary function tests (PFT):
- •DLCO >70% of predicted
- •FEV1/FVC > lower limit of normal per local PFT lab and FEV1 >70% predicted
- •Patients should be able to perform at least three acceptable FEV1, FVC, and DLCO maneuvers
- •[9] patients who have a chest x-ray (posteroanterior and lateral views) without evidence of clinically significant pulmonary abnormalities, in the opinion of the investigator
- •[10]patients who have signed and dated the informed consent document.
- •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
- •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.
- •[12] patients are Lilly employees or are employed by Alkermes. Immediate family of Lilly or Alkermes employees may participate in Lilly-sponsored clinical trials, but are
- •not permitted to participate at a Lilly facility.
- •[13] patients who 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 entry,
- •[14] patients who have previously received any form of inhaled insulin, or have 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. 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 two episodes of severe hypoglycemia
- •during the 6 months prior to study entry
- •[17] patients who have had more than one hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry,
- •[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 three 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 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] 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 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 or past history of asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, or other clinically relevant pulmonary disease that, in the opinion of the investigator, would preclude participation in the study due to safety concerns, or confound data interpretation,
- •[27] patients who are taking or have taken exenatide (Byetta™) or other incretin mimetics that are not approved for use with insulin during the prior 8 weeks,
- •[28] patients who have any other condition (including reported drug abuse, alcoho
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