NEW YORK (Reuters Healtth) ”These Phase II results in basal insulin-treated patients with type 2 diabetes showed that LY2605541 improved glycemic control comparable to that seen with insulin glargine and produced additional effects, such as weight loss, lower nocturnal hypoglycemia and less variability of blood glucose readings within the same day with similar hypoglycemia rates as insulin glargine,” Dr. Melvin J. Prince told Reuters Health by email.
Dr. Prince of Eli Lilly and Company, Indianapolis, Indiana and his colleagues came to this conclusion after studying patients who were taking metformin and/or sulfonylurea with insulin glargine or NPH insulin once daily.
As reported October 9th online in Diabetes Care, the patients continued with metformin and sulfonylurea and were randomized to open-label LY2605541 or glargine. In all, 195 received the new agent and 95 took glargine once daily in the morning.
At 12 weeks, fasting blood glucose was similar in the LY2605541 and glargine groups (118.2 vs 116.9 mg/dL). This was also the case for hemoglobin A1C levels (7.0% vs 7.2%).
Intra-day blood glucose variability was reduced with LY2605541 (34.4 vs 39.1 mg/dL). In addition, the LY2605541 patients lost a mean of 0.6 kg in weight, whereas the glargine patients gained 0.3 kg.
The incidence and rate of both total hypoglycemia and nocturnal hypoglycemia were comparable. However, after adjusting for baseline hypoglycemia, there was a 48% reduction in nocturnal hypoglycemia with the new agent.
Adverse events were similar across treatments. Although alanine aminotransferase and aspartate aminotransferase were significantly higher with LY2605541, they remained within normal range.
Summing up, Dr. Prince concluded, ”We will need to see if these results are replicated in our ongoing Phase III clinical development program for our novel basal insulin analog.”
If Phase 3 trials are successful, the company could submit the molecule to regulatory authorities as early as 2014.
The study was funded by Eli Lilly and Company. Along with Dr. Prince, a number of other authors are employees of the company.
Diabetes Care 2012 Oct
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