PER-038-05已完成未知
Multicenter, randomized, double-blind, placebo-controlled, parallel groups of efficacy and safety of WelChol® in type 2 diabetic patients on insulin therapy alone or insulin in combination with other oral antidiabetics in inadequate glycemic control
SANKYO PHARMA DEVELOPMENT,0 个研究点目标入组 0 人开始时间: 2005年9月20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
入选标准
- •1) Age: between 18 and 75 years inclusive.
- •2) Diagnosis of type 2 diabetes mellitus.
- •3) Patients will be receiving an optimal stable dose of insulin in a range> 30 but <200 units per day for 6 weeks before Visit 1.
- •4) Peptido C >0,5 ng/mL
- •5) Have prescribed a diet accepted by ADA.
- •6) If you are receiving other oral antidiabetic medications, the dose was stable for 90 days before Visit 1.
- •7) Understand the study procedures and agree to participate in the study by signing the informed consent.
- •8) Women can be included if the following 3 criteria are met: A) That they are not pregnant. B) That they are not breastfeeding. C) That they do not plan to become pregnant during the study.
- •9) In addition to all the above criteria, women must also meet 1 of the following 3 criteria: A) Having undergone a hysterectomy or tubal ligament for at least 6 months before signing the informed consent form. B) Being in the post-menopausal period for at least 1 year. C) If they are of childbearing age, they will practice 1 of the following methods of contraception throughout the study: oral contraceptives, injectables or hormonal implants, intrauterine device, diaphragm plus spermicide or female condom plus spermicide.
排除标准
- •1)History of type 1 diabetes and / or ketoacidosis
- •2)History of dysphagia, disorders in swallowing or intestinal motility.
- •3)Any serious disorder including those of the pulmonary, hepatic, gastrointestinal, endocrine / metabolic type uncontrolled, hematologic / oncological, neurological and psychiatric diseases.
- •4)Acute coronary syndrome, percutaneous coronary intervention, temporary ischemic attack within 3 months of Visit 1 or a history of severe peripheral vascular disease.
- •5)History of pancreatitis.
- •6)Antecedents of acquired immunodeficiency syndrome or human immunodeficiency virus.
- •7)History of drug or alcohol abuse within the last 2 years.
- •8)Admission for any reason within the 14 days prior to Visit 1.
- •9)History of an allergic or toxic response to colesevelam or any of its components.
- •10)Uncontrolled hypertension.
- •11)serum LDL-C <60 mg / dL.
- •12)Serum TG> 500 mg / dL.
- •13)Body mass index (BMI)> 45 kg / m2.
- •14)Patients with a program with continuous weight loss or beginning of an intensive program of exercises within 4 weeks of Visit 1.
- •15)Treatment with WelChol within 8 weeks of Visit 1 (week -3).
- •16)Any laboratory value during the selection outside the range of normal values unless approved by the medical monitor and the sponsor.
- •17)Any condition or therapy that, in the opinion of the investigator, could put the patient at risk or make the patient s participation not for their benefit.
- •18)Decreased mental function or any other reason that makes it difficult for the patient to comply with the requirements of the study.
- •19)Use of any experimental drug within 30 days preceding the first dose of the study medication.
- •20)Be an employee of the research center.
- •21)Family relationship with the sponsor or with the staff of the clinical trial center.
研究者
相似试验
进行中（未招募）
不适用
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s DiseaseEUCTR2007-000189-19-BEItalfarmaco S.p.A.80
进行中（未招募）
1 期
Study to investigate the efficacy and safety of dronabinol in the improvement of chemotherapy-induced and tumor-related symptoms in patients with advanced pancreatic cancer during first-line chemotherapyEUCTR2019-000616-28-ATAGMT gGmbH104
进行中（未招募）
1 期
Assessment of efficacy of CR8020 and CR6261, monoclonal antibodies, against influenza infectioMedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsInfluenzaEUCTR2013-003341-41-BECrucell Holland B.V.296
进行中（未招募）
不适用
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisrelapsing-remitting multiple scelorsisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2008-006786-92-HUActelion Pharmaceuticals Ltd400
进行中（未招募）
1 期
Multicenter, randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the efficacy, safety, and tolerability of ACT-128800, an S1P1 receptor agonist, administered for 6 weeks to subjects with moderate to severe chronic plaque psoriasisEUCTR2008-001443-19-FRActelion Pharmaceuticals Ltd60