Data came from patients in twelve controlled and five uncontrolled exenatide BID and four controlled exenatide once weekly trials.
Glycaemic control was assessed at each 12-weekly trial visit with self-measured plasma glucose readings and HbA1c.
The research nurse for this study contacted the patients weekly after trial initiation to assess toxicity, using the definitions and criteria for grading provided in the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
The Diabetes Therapy Utilization: Researching Changes in A1c, Weight and Other Factors Through Intervention with Exenatide Once Weekly (DURATION) trials were a series of clinical studies designed to test the superiority of exenatide once weekly as compared to currently available T2DM medications.
In 24 junior high schools, approximately 6,000 were enrolled in each of the three years of randomized weekly supplementation trials.
Trial weekly payments for staying in school have yielded a 5% increase in participation rates.
Subjects were evaluated weekly throughout the trial to track progress and monitor any safety issues.
The Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide Once Weekly (DURATION-1) trial was designed as a two-stage protocol.
Quarter milk samples were collected and tested weekly before the trial to ensure that they contained <50,000 somatic cells/ml and were free of mastitis pathogens.
11 In the DURATION-5 trial, weekly exenatide was compared against 5 µg exenatide twice daily for 4 weeks followed by 10 µg for 20 weeks.
However, according to the TAX327 trial, weekly D was not equally effective when compared with D given at 3-week intervals in the treatment of advanced CRPC, and furthermore, weekly D was not superior to mitoxantrone (Tannock et al, 2004).
