A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naÃ¯ve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

Boehringer Ingelheim Pharma GmbH Co0 个研究点目标入组 792 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment drug naÃ¯ve patients or previously treated patients with not more than one oral antidiabetic drug. Antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent
•2. Diagnosis of type 2 diabetes prior to informed consent
•3. Glycosylated haemoglobin A1c (HbA1c) at Visit 1a (Screening): For patients undergoing wash-out (pre-treated patients): HbA1c ≥ 7.0 to ≤ 10.5 %
•For naÃ¯ve patients not undergoing wash-out: HbA1c ≥ 7.5 to < 11.0%
•4. Glycosylated haemoglobin A1c (HbA1c) ≥ 7.5 to < 11.0% at Visit 2
•(Start of Run-in)
•5.Patients with very poor glycaemic control [HbA1c ≥ 11 %, determined by examination at Visit 1a (naÃ¯ve patients) or at Visit 2 (naÃ¯ve and pre-treated patients)] will be eligible to participate in an additional open-label study arm
•6. Age ≥ 18 and ≤ 80 years at Visit 1a (Screening)
•7. BMI (Body Mass Index) ≤ 40 kg/m2 at Visit 1a (Screening)
•8. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

•A history of coronary heart disease or stroke, serum creatinine >1.5 mg/dl, albuminuria >40 μg/min, and use of lipid-lowering drugs, aspirin, or other antihypertensive agents.

发起方

Boehringer Ingelheim Pharma GmbH Co