Lilly (LLY), Boehringer Ingelheim Report Mixed Data for LY2605541 in Type 1 and 2 Diabetes Patiets
Tweet Send to a FriendGet Alerts LLY Hot Sheet
Price: $55.14 +0.22%
Overall Analyst Rating:
NEUTRAL (
Down)
Dividend Yield: 3.5%
Revenue Growth %: 0.0%
Overall Analyst Rating:
NEUTRAL (
Down)Dividend Yield: 3.5%
Revenue Growth %: 0.0%
Trade LLY Now!
Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim announced results from two Phase II studies of their investigational novel basal insulin analog, LY2605541. Results of the type 1 diabetes study showed that LY2605541 was associated with greater improvements of glycemic control (lowering blood sugar levels) than insulin glargine. In the type 2 diabetes study, the primary measure showed that LY2605541 and insulin glargine had similar improvements in glycemic control. These data and additional measures from the studies will be presented at the 72nd American Diabetes Association (ADA) Scientific Sessions® in Philadelphia, June 8-12, 2012.
"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 and produced additional effects, such as weight loss and less variability of blood glucose readings, both within the same day and between days," said Richard Bergenstal, MD, executive director, International Diabetes Center at Park Nicollet and clinical professor, Department of Medicine, University of Minnesota.
"Lilly and Boehringer Ingelheim are excited to have the opportunity to share both the pre-clinical and clinical study data completed to date for LY2605541, and are pleased that these Phase II study results support the continued clinical development of this basal insulin," said David Kendall, MD, distinguished medical fellow, Lilly Diabetes. "Based on the pre-clinical studies completed, compared to injected human insulin, LY2605541 appeared to work preferentially in the liver, which is more like the body's own insulin. We look forward to results from our ongoing Phase III clinical trials."
Glycemic ControlIn adults with type 1 diabetes, patients treated with LY2605541 showed better glycemic control after eight weeks than those who received 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 glargine-treated patients had a 7 percent increase (the difference between treatments is statistically significant).
In patients with type 2 diabetes, LY2605541 and glargine had similar effects on lowering average daily self-monitored fasting (before breakfast) glucose levels, and A1C over 12 weeks.
Weight In both studies, treatment with LY2605541 was associated with weight loss, and statistically significant differences in weight compared to insulin glargine.
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. Glargine 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).
Glucose VariabilityIn 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 glargine (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).
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
"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 and produced additional effects, such as weight loss and less variability of blood glucose readings, both within the same day and between days," said Richard Bergenstal, MD, executive director, International Diabetes Center at Park Nicollet and clinical professor, Department of Medicine, University of Minnesota.
"Lilly and Boehringer Ingelheim are excited to have the opportunity to share both the pre-clinical and clinical study data completed to date for LY2605541, and are pleased that these Phase II study results support the continued clinical development of this basal insulin," said David Kendall, MD, distinguished medical fellow, Lilly Diabetes. "Based on the pre-clinical studies completed, compared to injected human insulin, LY2605541 appeared to work preferentially in the liver, which is more like the body's own insulin. We look forward to results from our ongoing Phase III clinical trials."
Glycemic ControlIn adults with type 1 diabetes, patients treated with LY2605541 showed better glycemic control after eight weeks than those who received 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 glargine-treated patients had a 7 percent increase (the difference between treatments is statistically significant).
In patients with type 2 diabetes, LY2605541 and glargine had similar effects on lowering average daily self-monitored fasting (before breakfast) glucose levels, and A1C over 12 weeks.
Weight In both studies, treatment with LY2605541 was associated with weight loss, and statistically significant differences in weight compared to insulin glargine.
- LY2605541-treated patients with type 1 diabetes lost weight, while glargine-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 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 glargine 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 glargine).
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. Glargine 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).
Glucose VariabilityIn 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 glargine (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).
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- EMA Approves MAA for Gilead's (GILD) Sofosbuvir
- From Research Labs to Doctors' Offices, Health Care Providers at Lilly Play Important Role in Bringing New and Innovative Medicines to Patients
- UPDATE: Senate Takes Aim at Apple (AAPL); Says Irish Unit Earned $22B, Paid $10M in Taxes
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
