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

ovartis Pharma Services AG0 个研究点目标入组 525 人2007年9月26日

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注册库

who.int

开始日期

2007年9月26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
•Patients treated with an AGI can only enter the study if their GFR is \= 30 mL/min/1\.73 m2; in addition, each country should comply with its local label for the use of AGIs in patients with renal impairment
•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 of \< 50 mL/min/1\.73 m2 at visit 1
•5\. HbA1c of \= 6\.5 and \= 10 % at visit 1
•6\. 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 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

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 current lower extremity diabetic skin ulcer
•8\. Patients taking TZDs with established peripheral edema