PER-029-13未知未知
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM PARALLEL-GROUP, MULTICENTER, 24-WEEK STUDY ASSESSING THE SAFETY AND EFFICACY OF LIXISENATIDE IN OLDER PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON THEIR CURRENT DIABETES TREATMENT REGIMEN.
Sanofi Aventis Recherche & Development,0 个研究点目标入组 77 人开始时间: 2013年10月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 70 至 100（—）
- 性别
- All
入选标准
- •Older patients, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic regimen
- •Signed written informed consent
排除标准
- •At screening: HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older patients and that this is the responsibility of the investigator to include the patient based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia (see Section 4.1.4)
- •At screening: patients on both basal insulin and sulfonylurea or basal insulin and meglitinides
- •At screening: FPG >250 mg/dL (>13.9 mmol/L)
- •Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.
- •Type 2 diabetes mellitus diagnosed less than 1 year prior to screening
- •Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening
- •Treatment within the 3 months preceding the screening with anti-diabetic agent other than allowed background therapy.
- •Allowed therapy includes metformin, sulfonylurea [except glibenclamide >10 mg, glicazide >160 mg], meglitinides [except repaglinide >6 mg], pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population.
研究者
相似试验
未知
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF PIRFENIDONE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSISPER-071-11InterMune, Inc.,44
进行中（未招募）
1 期
This is a study of two investigational drugs called onartuzumab and bevacizumab that are being tested alone or in combination with each other for the treatment of a specific type of brain tumor called glioblastoma.Patients with recurrent GlioblastomaMedDRA version: 14.1 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005912-27-GBF. Hoffmann-La Roche Ltd.129
进行中（未招募）
不适用
A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.MedDRA version: 15.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 10021428 - Immune system disordersEUCTR2012-003057-29-SKXencor Inc.58
进行中（未招募）
1 期
A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.MedDRA version: 16.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870EUCTR2012-003057-29-HUXencor Inc.58
进行中（未招募）
不适用
A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.MedDRA version: 16.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870EUCTR2012-003057-29-CZXencor Inc.58