A 78 week open label extension to trials assessing the safety and efficacy of BI 10773 as monotherapy or in combination with Metformin in type 2 diabetic patients - ND

BOEHRINGER ING.0 个研究点目标入组 860 人开始时间: 2009年4月20日最近更新: 2012年7月10日

适应症

试验速览

暂无简介。

•1. Patients completing the entire treatment period of the preceding double-blind trial 1245.9 or 1245.10. 2. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.
•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

•1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.9 or 1245.10. 2. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) based on the last available lab result received during the preceding trial. 3. Renal insufficiency or impaired renal function defined by creatinine clearance <50 mL/min (calculated) or serum creatinine levels in men >= 1.5 mg/dL; in women >=1.4 mg/dL based on the last available lab result received during the preceding trial. 4. For Patients on Metformin therapy: additional contraindications to Metformin which started during trial participation in 1245.10 or 1245.9: 5. Pre-menopausal women (last menstruation >= 1 year prior to signing informed consent) who: are nursing or pregnant, or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. 6. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation. 7. Drug abuse that in the opinion of the investigator would interfere with trial participation. 8. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

发起方

BOEHRINGER ING.