课件：艾塞那肽临床药理学与临床应用.ppt

* * * CITATIONBarnett AH, Burger J, Johns D, et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clin Ther. 2007;29:2333-2348. SEEpg 2337 Table (for slide data); pg 2335 “Patients” (for DISCUSSION); pg 2335 “Study design” (for background information) DISCUSSION Inclusion criteria: Study participants were ≥30 years old, and had 3 months prior treatment with either a stable dose of ≥1500 mg/day immediate- or extended-release metformin (MET) or an optimally effective dose of a sulphonylurea (SFU). Patients had an HbA1c ≥7.1% and ≤11.0%, a body mass index (BMI) 25 kg/m2 and 40 kg/m2, and stable body weight (not varying by 10%) for ≥3 months. At baseline, patients in the two treatment sequences were similar in mean age, BMI, fasting serum glucose (FSG), and HbA1c STUDYH8O-MC-GWAO BACKGROUND Randomised, open-label, 2-period crossover noninferiority study of patients with type 2 diabetes previously uncontrolled with MET or an SFU. Exenatide and insulin glargine treatments were administered for 16 weeks each and prestudy dose of MET or SFU was continued. Exenatide was administered twice daily as subcutaneous injection, 60 min before AM and PM meals at 5 μg for first 4 weeks, 10 μg exenatide after 4 weeks. Once-daily insulin glargine treatment was initiated at 10 IU, and was increased weekly by 8, 6, 4, or 2 IU daily if the mean fasting serum glucose (FSG) level on two consecutive days was 10 mmol/L, 7.8 to 10 mmol/L, 6.7 to 7.8 mmol/L, or 5.6 to 6.7 mmol/L, respectively. However, if the mean FSG level was less than 4 mmol/L at any time during the previous week, the insulin glargine dose was not adjusted. * CITATIONBarnett AH, Burger J, Johns D, et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes pre