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In the Phase II study, known as GBCJ, LY2189265 was significantly superior to placebo in reducing key measures of glycemic control, including fasting serum glucose and hemoglobin A1C (HbA1C). In this study, LY2189265 showed an insulinotropic effect, suggesting it produced the desired outcome in participants. In study GBCJ, LY2189265 was generally well-tolerated, said Lilly.
In the 16-week, Phase II study of LY2189265, 262 patients with type 2 diabetes who were suboptimally controlled on at least two oral diabetes medicines were randomized to one of four arms: 1mg of LY2189265 for 16 weeks; 0.5mg of LY2189265 for four weeks followed by 1mg for 12 weeks; and 1mg of LY2189265 for four weeks followed by 2mg for 12 weeks or placebo.
The primary endpoint was glycemic control, as measured by change from baseline in HbA1C; additional endpoints evaluated included changes in fasting serum glucose, solid mixed meal glucose excursion and body weight. For all doses in this study, statistically significant reductions in all metabolic measures were observed. Both 1mg and 2mg doses of LY2189265 were significantly different from placebo, but no significant differences between the doses were seen, the company added.
Steve Paul, executive vice president of science and technology, and president of Lilly Research Laboratories, said: "Given our more than 80 years of experience in pioneering diabetes treatments, we are encouraged by these data. In this study, LY2189265 was administered once weekly and demonstrated significant glucose-lowering activity and reduced body weight, supporting its potential to become a new treatment option for the millions of people with type 2 diabetes."
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