Please obtain the paper by DeFronzo et al. (2005), “Effects of Exenatide (Exendin-4) on Glycemic Control and Weight Over 30 Weeks in Metformin-Treated Patients With Type 2
Diabetes”
2 pages/short answer the questions below: (don’t count questions)
• Which company was the sponsor of the trial?
• What was the overall purpose of the trial?
• What were the primary end points?
• What were the secondary end points?
• What were the main inclusion criteria?
• What were the main exclusion criteria?
• Make a drawing of your choice to show the treatment in each arm, including the lead-in
period, the acclimation period, and the study period.
• At how many sites was the trial performed, and in which countries? On average, how
many patients participated in this trial in each site?
• How was the intent-to-treat population defined?
• How was the evaluable population defined?
• Why do you think it was correct to assess safety in the intent-to-treat population and not
in the evaluable population?
• Look at Figure 1. Make your own little table showing for each group, the total number of
patients, the number of patients withdrawn for adverse events, and those withdrawn for
loss of glucose control. In a bullet, propose a rational hypothesis to explain these
numbers.
• Show the bar chart with the % of patients achieving A1C ‰¤ 7% in each group.
• Put yourself in the position of a prescriber. If you prescribe 10 ug exenatide BID to 100
of your T2D patients who fulfill the inclusion criteria of this trial, how many of these
patients will fail to reduce HbA 1C to below 7% after 30 weeks of treatment?
• Show the plots of postprandial plasma glucose and plasma insulin at 30 weeks after the
meal tolerance test. Explain why plasma glucose is lower for the 5 ug dose of exenatide
than for the placebo up to 90 min when there is no difference in plasma insulin within
these two groups up to 90 min.
• Look at Table 1, but do not paste it in your slides. Create a bullet explaining the two most
significant treatment emergent adverse effects and their relationship with the dose of
exenatide.
• Comment in a bullet on the incidence of hypoglycemia in this trial.