Single centre, double-blind, randomised, placebo controlled, cross-over study to investigate the effects of postprandial glucose reduction by acarbose on insulin sensitivity and cardio-vascular markers in type 2 diabetes patients, subjects with impaired glucose tolerance and normal glucose tolerant subjects

Bayer Schering Pharma AG (Germany)0 个研究点目标入组 70 人开始时间: 2010年6月29日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Males or females, aged between 18 and 75 years inclusive
•2. Newly diagnosed type 2 diabetes, or previously treated with diet and/or exercise or treated with metformin or acarbose as monotherapy or with impaired glucose tolerance (IGT)/impaired fasting glucose (IFG) or with normal glucose tolerance
•3. Female patients were either non-fertile or willing to use a medically approved birth control method during the whole duration of the study
•4. Body mass index (BMI) between 20 and 40 kg/m^2
•5. Fasting plasma glucose (FPG) less than 15 mmol/1
•6. Fasting C-peptide greater than 1 ng/ml

•1. On treatment with insulin, insulin secretagogues, corticosteroids (with the exception of inhaled corticosteroids), thiazolidindiones derivates and monoaminooxidase inhibitors
•2. Known sensitivity to drugs similar to acarbose
•3. Serum creatinine greater than 1.5 mg/dl or pre-existing end-stage nephropathy
•4. On laser treatment for diabetes related retinopathy within 3 months prior to study start
•5. Alanine aminotransferase (ALAT) greater than 2.5 times of normal range
•6. Type 1 diabetes mellitus
•7. Thyroid stimulating hormone (TSH) outside of normal range
•8. Medical history or signs of chronically gastrointestinal diseases with diarrhoea, flatulence and absorption anomalies

发起方

Bayer Schering Pharma AG (Germany)