EUCTR2005-004747-64-HU进行中（未招募）不适用
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial InjectableInsulin in Insulin-Naïve Patients with Type 2 Diabetes Mellitus - IDA
Eli Lilly and Company Ltd0 个研究点目标入组 420 人开始时间: 2006年2月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
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:
- •[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
- •[3]Patients taking at least one oral anti-hyperglycemic medication
- •[4]Patients with HbA1c =6.5% and =10.0% at screening
- •[5]Female patients who are not breastfeeding, tested negative for
- •pregnancy at the time of screening and do not intend to become pregnant
- •during study.
- •[6]Patients who are nonsmokers, have not smoked for at least 6 months
- •prior to entering the study, and agree not to smoke for the duration of the
- •[7]Patients who are able to perform pulmonary function testing, according to
- •guidelines from the American Thoracic Society (ATS) (1995)
- •[8]Patients who have Pulmonary function tests (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 three acceptable
- •FEV1, FVC, and DLCO maneuvers
- •[9] Patients who have a chest x-ray without evidence of clinically significant
- •pulmonary abnormalities (including severe bullous disease), 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
- •[1]Patients who are investigator site personnel directly affiliated with the
- •study, or are immediate family of investigator site personnel directly
- •affiliated with the study.
- •[2]Patients who are employed by Lilly or 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.
- •[3]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
- •[4]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
- •[5]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 (e.g., 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 excluded.
- •[6]Patients who have had more than two episodes of severe hypoglycemia
- •during the 6 months prior to study entry.
- •[7] 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.
- •[8]Patients who have had a lower respiratory infection in the 6 months prior
- •to screening, evidenced by diagnosed pneumonia.
- •[9]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)
- •[10]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
- •[11]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 (e.g., in the United States, more than or equal 1.5
- •mg/dL [132 µmol/L] for males or more than or equal 1.4 mg/dL [123
- •µmol/L] for females)
- •[12]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 IDAU.5]) within the 6 months
- •prior to study entry
- •[13]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 t
研究者
相似试验
进行中（未招募）
不适用
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial InjectableInsulin in Insulin-Naïve Patients with Type 2 Diabetes Mellitus - IDAMale or female adults (>18 yrs), diagnosed type 2 diabetes mellitus for at least 6 months duration at study entry, taking at least one oral anti-hyperglycemic medication and are insulin-naïve. They should have a HbA1c =6.5% and =10.0% at the time of screening.EUCTR2005-004747-64-DEEli Lilly and Company Ltd420
进行中（未招募）
不适用
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder HIIP Compared to Preprandial Injectable Insulin in Patients with Type 1 Diabetes Mellitus. - NDMedDRA version: 6.1Level: PTClassification code 10012601Type 1 Diabetes MellitusEUCTR2006-000497-80-ITELI LILLY320
进行中（未招募）
不适用
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder HIIP Compared to Preprandial Injectable Insulin in Insulin-Na ve Patients with Type 2 Diabetes MellitusEUCTR2005-004747-64-ITELI LILLY420
进行中（未招募）
不适用
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial InjectableInsulin in Insulin-Naïve Patients with Type 2 Diabetes Mellitus - IDAMale or female adults (>18 yrs), diagnosed type 2 diabetes mellitus for at least 6 months duration at study entry, taking at least one oral anti-hyperglycemic medication and are insulin-naïve. They should have a HbA1c =6.5% and =10.0% at the time of screening.EUCTR2005-004747-64-PTEli Lilly and Company Ltd420
进行中（未招募）
不适用
A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial InjectableInsulin in Patients with Type 1 Diabetes Mellitus - IDAVMale or female nonsmoking patients 18 years of age or older who have had type 1 diabetes mellitus for at least 24 months at study entry and are taking at least 2 or 3 preprandial injections per day for at least 2 months, have FEV1 and DLCO >70% predicted, and have an HbA1c less or equal 11.0% at screening.EUCTR2006-000497-80-BEEli Lilly and Company Ltd320