A phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of once daily oral administration of linagliptin 5 mg/BI 10773 25 mg and linagliptin 5 mg/BI 10773 10 mg Fixed Dose Combination tablets compared with the individual components linagliptin 5 mg, BI 10773 25 mg, and BI 10773 10 mg) for 52 weeks in treatment naïve and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control

Boehringer Ingelheim RCV GmBH & Co KG0 个研究点目标入组 1,300 人开始时间: 2011年7月11日最近更新: 2013年12月16日

适应症

试验速览

暂无简介。

•1. Diagnosis of type 2 diabetes mellitus prior to informed consent
•2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
•3. HbA1c = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 975
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 325

•1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
•2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
•3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent

发起方