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 - ND

OVARTIS FARMA0 个研究点目标入组 300 人2007年11月13日

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注册库

who.int

开始日期

2007年11月13日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

OVARTIS FARMA

入排标准

入选标准

•Age in the range of 18\-85 years inclusive at visit 1 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, alpha\-glucosidase inhibitors (AGIs), thiazolidinediones (TZDs), insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1 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) GFR estimated by the Cockcroft\-Gault formula of ≥ 30 and \<50 mL/min at visit 1 HbA1c of ≥ 6\.5 and ≤ 10% at visit 1 Body weight \< 120 kg and body mass index (BMI) 18\-42 kg/m2 at visit 1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

排除标准

•FPG ≥ 270 mg/dL (≥15 mmol/L) Pregnant or lactating female History of renal transplant at any time in the past Any pre\-existing lower extremity diabetic skin ulcer Patients taking TZDs with established peripheral edema Congestive heart failure (New York Heart Association (NYHA) Class III\-IV) Liver disease, such as cirrhosis, or chronic active hepatitis B and C Patients undergoing any method of dialysis (hemodialysis or peritoneal dialysis) or on the dialysis list at visit 1 Treatment with current anti\-diabetic therapy other than sulfonylureas, AGIs, TZDs insulin, and metiglinides within 8 weeks prior to visit 1 Treatment with any medication that is contraindicated in the renal impaired population (GFR \< 50 mL/min: calculated by the Cockcroft\-Gault formula) Any of the following significant laboratory abnormalities: Clinically significant thyroid stimulating hormone (TSH) outside of normal range at visit 1 Clinically significant laboratory abnormalities at the opinion of the investigator Patients with a serum albumin \< 3\.0 g/dL at visit 1 Patients with a hemoglobin concentration \< 9 g/dL at visit 1 Elevated fasting triglycerides \> 500 mg/dL at visit 1, confirmed by a repeat measure within 3 working days Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN) at visit 1, confirmed by a repeat measure within 3 working days Total bilirubin \> 2 x ULN and/or direct bilirubin greater than the ULN at visit 1, confirmed by a repeat measure within 3 working days History of spontaneous or drug induced muscle symptoms (not associated with exercise and/or physical activity), and/or elevated CPK (\> 3 x ULN) confirmed by a repeated measure within 3 working days A positive Hepatitis B test (surface antigen \- HbsAg) A positive Hepatitis C test (HCV antibodies)