A multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of 24 weeks treatment with vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with type 2 diabetes and moderate renal insufficiency

ovartis Pharma Services AG0 个研究点目标入组 300 人2008年2月12日

适应症Diabetes Type 2 MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Diabetes Type 2
发起方: ovartis Pharma Services AG
入组人数: 300
状态: 进行中（未招募）
最后更新: 13年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2008年2月12日

结束日期

待定

最后更新

13年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

ovartis Pharma Services AG

入排标准

入选标准

•1\.Age in the range of 18\-85 years inclusive at visit 1
•2\.Patients with T2DM either untreated (defined as not taking anti\-diabetic therapy for at least 8 weeks prior to visit 1\) or treated with anti\-diabetic therapy defined as sulfonylurea, AGIs, TZDs, insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1
•3\.Patients treated with anti\-diabetic therapy must be on a stable dose for the past 4 weeks prior to visit 1 (stable insulin therapy is defined as ± 20% of total daily units)
•4\.GFR estimated by the Cockcroft\-Gault formula of \= 30 and \< 50 mL/min at visit 1
•5\.HbA1c of \= 6\.5 and \= 10 % at visit 1
•6\.Body weight \< 120 kg and body mass index (BMI) 18\-42 kg/m2 at visit 1
•7\.Male, non\-fertile female or female of childbearing potential using a medically approved birth control method by the country health authorities that may include:
•A non\-fertile female is defined as: post menopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mLU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation
•A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means
•Medically approved birth control methods may include: hormonal contraceptives, intrauterine contraceptive device (IUD), and double\-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post\-ovulation methods) and withdrawal are not acceptable methods of contraception

排除标准

•1\.FPG \= 270 mg/dL (\=15 mmol/L)
•2\.Pregnant or lactating female
•3\.A history of:
•Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly
•Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
•4\.Patients that have been enrolled in a vildagliptin clinical trial or other DPP\-4 inhibitor, GLP\-1 mimetics (e.g. exenatide), GLP\-1 analogues (e.g. liraglutide) studies within six months prior to visit 1
•5\.History of renal transplant at any time in the past
•6\.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
•7\.Any pre\-existing lower extremity diabetic skin ulcer
•8\.Patients taking TZDs with established peripheral edema