Once Weekly Blood Glucose Control: Once a week glucose control shots are what some drug manufacturers are hoping for. In the most recent phase of testing the results seem to indicate it may be possible. These possibilities would have great meaning for Type 2 diabetics.
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. have been working together to determine if the drug exenatide is superior to other diabetes drugs sitagliptin or pioglitazone, which are both oral medications.
According to a press release by the manufacturers of exenatide, “This 26-week clinical study compared exenatide once weekly to maximum doses of sitagliptin or pioglitazone in 491 patients with type 2 diabetes taking stable doses of metformin. After completing 26 weeks of treatment, evaluable patients randomized to exenatide once weekly experienced a statistically significant reduction in A1C, a measure of average blood sugar over three months, of 1.7 percentage points from baseline, compared to a reduction of 1.0 percentage point for sitagliptin and 1.4 percentage points for pioglitazone. Treatment with exenatide once weekly also produced statistically significant differences in weight, with weight loss of 6.2 pounds at 26 weeks, compared with a loss of 1.9 pounds for sitagliptin, and a weight gain of 7.4 pounds for pioglitazone.”
The combination of improved blood glucose control and a swing of over 13 pounds between patients who used exenatide verses pioglitazone caused Dr. Jim Malone, global medical director for exenatide to declare, “The results of this study provide us with more insight into the potential profile that may be achieved with exenatide once weekly. As we continue to progress through the series of DURATION studies, our goal is to clearly understand how exenatide once weekly compares to other diabetes therapies and be able to articulate, through the data, these differences to patients and their healthcare providers.”
Eighty percent of patients who started this study went on to complete the 26-week trial. The most common side effect among those who used the exenatide injections was nausea and diarrhea. These were the same side effects common among patients using sitagliptin. In pioglitazone the common side effects included fluid retention and accompanying swelling in the lower limbs along with upper respiratory tract infections.
Richard Bergenstal, M.D., executive director of the International Diabetes Center commented on the findings by saying, “Recognizing the importance of A1C control, it has become clear that health care providers need comparative data to better understand the relative value of therapeutic options. A once-weekly therapy that helps patients achieve A1C targets, with the added benefits of weight loss and no major hypoglycemia, could provide patients with an important option to improve their diabetes care.”
The manufacturers provide their own disclaimer on the findings of this DURATION-2 study. [These findings], “contain forward-looking statements about Amylin, Lilly and Alkermes and the investigational drug, exenatide once weekly. Actual results could differ materially from those discussed or implied due to a number of risks and uncertainties, including the risk that exenatide once weekly may be affected by unexpected new data; safety and technical issues; and clinical trials, not being completed in a timely manner, not confirming previous results, or not achieving the intended clinical endpoints; the DURATION-2 superiority study results potentially not being predictive of real world use including results relative to other diabetes medications; pre-clinical trials not predicting future results; label expansion requests or New Drug Application (NDA) filings, including the NDA filing for exenatide once weekly, not being submitted in a timely manner; regulatory approval being delayed or not received; or manufacturing and supply issues. The potential for exenatide once weekly may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks.”
