EUCTR2009-015255-25-SE进行中（未招募）不适用
A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of linagliptin (5 mg), administered orally once daily over 24 weeks in type 2 diabetic patients (age > 70 years) with insufficient glycaemic control (HbA1c = 7.0) despite metformin and/or sulphonylurea and/or insulin therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female patients with diagnosis of T2DM and stable treatment prior to informed consent. Treatment with metformin and/or sulphonylurea has to be unchanged for 8 weeks prior to informed consent; the insulin dose should not have changed within the 8 weeks prior to informed consent by more than 20% from the baseline value at randomisation.
- •2. Glycosylated haemoglobin A1 (HbA1c) >= 7.0 % at Visit 1
- •3. Age >= 70 years at Visit 1
- •4. 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) no
- •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
- •1. Uncontrolled hyperglycaemia 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. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
- •3. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1
- •4. Bariatric surgery
- •5. Known hypersensitivity or allergy to the investigational product or its excipients or the patients’ baseline drug(s) or placebo
- •6. Treatment with glitazones, GLP-1 analogues or DPP-4 inhibitors within 3 months prior to informed consent
- •7. Treatment with rapid acting or pre-mixed insulins
- •8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
- •9. Active alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation
- •10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
- •11. Participation in another trial with an investigational drug within 2 months prior to informed consent
- •12. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol or study related procedures
- •13. Illness or concomitant disease/condition that may increase the risk associated with study participation and in the judgement of the investigator would make the patient inappropriate for entry into the study
研究者
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