PER-106-09已完成未知
A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2010年3月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 18 至 99（—）
入选标准
- •Patients with type 2 diabetes mellitus, as defined by CMS (WHO) (I), diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with metformin at a stable dose of at less 1.5 g / day for at least 3 months prior to the selection visit. In addition to metformin, patients may receive sulfonylureas (these should be suspended at visit I) and / or thiazolidinediones (this can be continued).
- •Obtain informed written consent
排除标准
- •In the age of selection • In the selection HbA1c <7.0 or HbA1c> 10%
- •Pregnancy or breastfeeding
- •Women with reproductive capacity without effective contraceptive method.
- •Type 1 diabetes mellitus
- •Metformin not in a stable dose of at least 1.5 g / day for at least 3 months prior to the selection visit.
- •Use of oral or injectable or hypoglycemic antidiabetic agents other than metformin, sulfonylurea and thiazolidinediones (eg alpha glucosidase inhibitor, other GLP-1 receptor agonists, DPP-IV inhibitors, insulin etc.) within 3 months prior to At the time of selection, use of medications to lose weight if they are not at a stable dose for at least 3 months prior to the selection visit.
- •History of ignorance of hypoglycemia.
- •Body Mass Index (BMI) <20 kg / m2
- •History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach / gastric surgery, inflammatory bowel disease
- •History of metabolic acidosis, including ketoacidosis within 1 year prior to selection
- •Hemoglobinopathy or hemolytic anemia, blood transfusion or plasma products within 3 months prior to the date of selection
- •Within the last 6 months prior to selection: a history of myocardial infarction, attack or heart failure requiring hospitalization
- •Known history of drug or alcohol abuse within 6 prior to the time of selection
- •Any clinically significant abnormality identified in the physical examination, laboratory tests, ECG or vital signs at the time of selection that, in the opinion of the investigator or some sub-investigator, could impede the completion of the study safely or restrict the evaluation of efficacy, such as major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema that would probably require laser treatment within the study period.
- •Hypertension not controlled or inadequately controlled at the time of selection with resting systolic or diastolic blood pressure> 180 mmHg or> 110 mmHg, respectively
- •Patients considered by the investigator or some sub-investigator as inappropriate for this study for any reason (eg, inability to meet the specific requirements of the protocol, such as scheduled visits, who are able to self-inject, who are prone to require treatment during the selection phase and treatment phase with drugs not allowed by the clinical study protocol, that the patient is the researcher or some sub-researcher, pharmacist, study coordinator, other study staff or relative from this directly involved in the protocol conduction, etc).
- •Use of systemic glucocorticoids (excluding topical application or inhaled forms) for a week or more within 3 months prior to the time of selection
- •Use of any investigational medication within 3 months prior to selection
研究者
相似试验
已完成
3 期
24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin GlargineCTRI/2009/091/000807SanofiSynthelabo India Limited450
进行中（未招募）
不适用
A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - NDEUCTR2008-007335-40-ITSanofi-Aventis Recherche & De`veloppement750
进行中（未招募）
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A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - GETGOAL DUO 1Type II DiabetesMedDRA version: 11.1Level: LLTClassification code 10045242Term: <Manually entered code. Term in E.1.1>EUCTR2008-007335-40-NLSanofi-Aventis Recherche & Développement950
进行中（未招募）
不适用
A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - GETGOAL DUO 1Type II DiabetesMedDRA version: 11.1Level: LLTClassification code 10045242Term: <Manually entered code. Term in E.1.1>EUCTR2008-007335-40-SESanofi-Aventis Recherche & Développement950
进行中（未招募）
不适用
A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - GETGOAL DUO 1Type II DiabetesMedDRA version: 11.1Level: LLTClassification code 10045242Term: <Manually entered code. Term in E.1.1>EUCTR2008-007335-40-PLSanofi-Aventis Recherche & Développement950