EUCTR2006-002245-36-CZ进行中（未招募）不适用
A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere®/Insulin in Combination with Metformin or Technosphere®/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-Optimally Controlled on Combination Metformin and a Secretagogue
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 525
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
- •Key inclusion criteria include: Non-smoking male and female subjects = 18 and = 80 years of age with clinical diagnosis of type 2 diabetes mellitus for = 6 months. Stable regimen of metformin = 1000 mg/day (or maximum tolerated dose) and a secretagogue (sulfonylurea or meglitinide) = ½ the maximum manufacturer-recommended daily dose (or maximum tolerated dose) without any dose adjustments within the preceding 6 weeks. Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria. HbA1c = 7.5% and = 11.0%. Body Mass Index (BMI) = 40 kg/m2. The following PFTs: FEV1 = 70 % National Health and Nutrition Examination Survey (NHANES) III Predicted, Total Lung Capacity (TLC) = 80% of Predicted (ITS) and single breath carbon monoxide diffusing capacity (DLco (unc)) = 80% of Predicted (Miller).
- •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
- •Key exclusion criteria include: Treatment with any type of anti-diabetic therapy, other than metformin and secretagogues (sulfonylureas or meglitinides), within the preceding 12 weeks. Serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects. History of chronic obstructive pulmonary disease (COPD), clinically proven asthma and/or any other clinically important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings. Evidence of serious complications of diabetes (eg, autonomic neuropathy).
研究者
相似试验
进行中（未招募）
不适用
A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine Menjugate® When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age with a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age;Healthy subjects without known medical conditions will be vaccinated against N. menigitidis serogroup C. Active prevention of menigococcal C disease caused by Neisseria menigitidisEUCTR2005-000924-18-DEovartis Vaccines and Diagnostics S.r.l.260
进行中（未招募）
1 期
F-627 is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropeniaEUCTR2016-003553-15-HUGeneron (Shanghai) Corporation Ltd.400
进行中（未招募）
1 期
F-627 is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropeniaEUCTR2016-003553-15-BGGeneron (Shanghai) Corporation Ltd.400
进行中（未招募）
1 期
F-627 is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropeniaWomen, between 18 and 75 years of age that have been diagnosed with Stage I-III breast cancer and are scheduled to undergo chemotherapy. This is a prophylaxis for myleotoxic chemotherapy induced neutropenia.MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2016-003553-15-LVGeneron (Shanghai) Corporation Ltd.400
进行中（未招募）
1 期
A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation.MedDRA version: 20.1Level: LLTClassification code 10055629Term: Paroxysmal nocturnal hemoglobinuriaSystem Organ Class: 100000004857EUCTR2017-004268-36-ESApellis Pharmaceuticals, Inc.80