At the 72nd American Diabetes Association (ADA) Scientific Sessions® last month, Eli Lilly and partner Boehringer Ingelheim presented data from two mid-stage (phase II) trials. In a press release from the two companies, the data presented showed that type 1 patients given the drug, code-named LY2605541, had lower daily average blood-sugar readings after eight weeks than those who received Lantus, and the reduction in HbA1c was greater among LY2605541 users than Lantus users.
In the other study of 290 type 2 patients, those taking LY2605541 had similar average daily blood sugar and HbA1c levels as those on Lantus, after 12 weeks of treatment.
In both studies, LY2605541 was associated with weight loss, while Lantus was associated with weight gain, which could be a key selling point. While the LY2605541 patients had a higher overall rate of low blood sugar episodes (hypoglycemia) than those on Lantus, the LY2605541 patients had a lower rate of nighttime hypoglycemia.
Dr. Richard Bergenstal, executive director, International Diabetes Center at Park Nicollet and clinical professor at the University of Minnesota was one of the investigators conducting the studies. He was encouraged by the results.
“As a clinical investigator, these Phase II results are intriguing, as they showed that LY2605541 improved glycemic control in patients with type 1 and type 2 diabetes,” Bergenstal said in the press release. “And produced additional effects, such as weight loss and less variability of blood glucose readings, both within the same day and between days.”
The companies said the data was sufficiently promising to move the study of LY2605541 into larger, late-stage (phase III) clinical trials, which could support a bid to seek regulatory approval for the product in 2014.
