Newly Presented results from two Phase II studies of Eli Lilly and Boehringer Ingelheim’s investigational novel basal insulin analog, LY2605541, show that that LY2605541 was associated with greater improvements of glycemic control (lowering blood sugar levels) than Lantus (insulin glargine) in patients with type 1 diabetes. Type 2 diabetes patients showed similar improvements in glycemic control when using LY2605541 and Lantus (insulin glargine).
In adults with type 1 diabetes, patients treated with LY2605541 showed better glycemic control after eight weeks than those who received Lantus (insulin glargine). LY2605541-treated patients’ average daily blood glucose readings (from self-testing) were significantly reduced (mean difference vs. glargine equaled -10 mg/dL), and their reduction in hemoglobin A1C (average blood glucose levels) was significantly greater (-0.6 percent from baseline vs. -0.4 percent from baseline for glargine). In addition, patients in the LY2605541 group had a 17 percent reduction in their mealtime insulin dose while Lantus-treated patients had a 7 percent increase (the difference between treatments is statistically significant).
In patients with type 2 diabetes, LY2605541 and Lantus had similar effects on lowering average daily self-monitored fasting (before breakfast) glucose levels, and A1C over 12 weeks.
In both studies, treatment with LY2605541 was associated with weight loss, and statistically significant differences in weight compared to Lantus (insulin glargine).
LY2605541-treated patients with type 1 diabetes lost weight, while Lantus-treated patients gained weight (mean change -2.65 lbs. [-1.2 kg] vs. +1.52 lbs. [+0.7 kg] for glargine), a -4.17-lb. [-1.9 kg] difference in mean weight change. The mean baseline weight was 183 pounds (83 kg).
A 5 percent or greater loss in body weight was statistically significantly more frequent in the LY2605541 group with type 1 diabetes (12 percent vs. 1 percent for glargine).
Type 2 patients treated with LY2605541 achieved significant mean weight loss (-1.28 lbs [-0.58 kg]) compared with Lantus (insulin glargine) (+0.68 lbs. [+0.31 kg]) at 12 weeks, a -1.85-lb. [-0.84 kg] difference in mean weight change compared to glargine-treated patients. The mean baseline weight for patients treated with LY2605541 was 200 pounds (91 kg) and for those treated with Lantus the mean baseline weight was 198 pounds (90 kg).
A 5 percent or more loss in body weight was more frequent in the LY2605541 group with type 2 diabetes (5 percent vs. 0 percent on Lantus).
LY2605541 was associated with a statistically significant higher overall hypoglycemia rate (blood glucose less than or equal to 70 mg/dL) in patients with type 1 diabetes (8.7 events/30 days vs. 7.4 events/30 days with Lantus), but a statistically significant lower rate of nocturnal hypoglycemia (0.9 events/30 days vs. 1.1 events/30 days with glargine). In the type 1 diabetes study, the unanticipated need for lower prandial (mealtime) insulin doses at study initiation contributed to the slightly higher rate of overall hypoglycemia with LY2605541 than with Lantus (insulin glargine). Despite the reduction later of mealtime insulin doses throughout the trial, glycemic control continued to improve throughout the study.
The treatments had similar overall rates of hypoglycemia in the type 2 study, but patients treated with LY2605541 had a 48 percent reduced rate of nocturnal hypoglycemia compared to glargine (0.25 vs. 0.39 events/30 days/patient, after adjusting for baseline hypoglycemia events).
In a subset of patients with type 2 diabetes, hypoglycemia was assessed by continuous glucose monitoring (CGM), which measures a person’s glucose level every five minutes for up to three days. Lantus treatment increased the time patients spent in hypoglycemia as measured by CGM. In contrast, in LY2605541-treated patients, the time spent in hypoglycemia was not different from baseline and was significantly less compared to glargine. Fewer LY2605541-treated patients experienced hypoglycemia episodes compared to glargine-treated patients (50.0 percent vs. 78.3 percent), and fewer LY2605541-treated patients also experienced nocturnal hypoglycemia events (20.5 percent vs. 47.8 percent).
In the type 1 study, LY2605541-treated patients showed less within-day glucose variability at eight weeks (i.e., their self-monitored blood glucose levels stayed within a narrower range) (standard deviation of 52 vs. 58 mg/dL).
In the type 2 study, there was a significant reduction in within-day blood glucose variability with LY2605541 compared to Lantus (standard deviation of 34 vs. 39 mg/dL). In the subset of patients with type 2 diabetes assessed by CGM, LY2605541-treated patients had statistically significant less within-day glucose variability compared with insulin glargine in both the nighttime period (standard deviation of 18 vs. 24 mg/dL) and the daytime period (standard deviation of 37 vs. 45 mg/dL).