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INDIANAPOLIS, June 6, 2015 /PRNewswire/ — Eli Lilly and Company’s (NYSE: LLY) basal insulin peglispro (BIL) consistently demonstrated superior hemoglobin A1c (HbA1c) reduction in people along with type 2 diabetes compared to insulin glargine across three Phase III trials. The results were presented today at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston.1,2,3
The trials compared BIL and insulin glargine in three common type 2 patient populations: those not previously using insulin (IMAGINE-2), those using basal insulin along with mealtime insulin (IMAGINE-4) and those currently using a basal insulin (IMAGINE-5).
“BIL is the initial and only basal insulin to consistently demonstrate superior glycemic benefits along along with a reduction in nocturnal hypoglycemia and a weight advantage compared to insulin glargine in Phase III clinical studies,” said Melanie Davies, M.D., professor of diabetes medicine, University of Leicester, United Kingdom. “Further innovation in basal insulin treatments is necessary as lots of people currently being treated do not reach glycemic targets and experience nocturnal hypoglycemia or weight gain.”
Additional data from IMAGINE-2, IMAGINE-4 and IMAGINE-five showed that a lot more patients taking BIL consistently met the ADA’s recommended HbA1c target of much less compared to 7 percent.4 A higher percentage of BIL-treated patients additionally reported much less nocturnal hypoglycemia compared to those on insulin glargine. Rates of total and severe hypoglycemia did not differ significantly between treatment groups. Patients taking BIL went through much less weight gain compared to patients taking insulin glargine in IMAGINE-2 and IMAGINE-4.
In all three clinical trials, patients taking BIL had an increase in the liver enzyme ALT (alanine aminotransferase), and triglyceride levels were better compared to in patients treated along with insulin glargine.1,2,3 Liver fat content was better after treatment along with BIL compared to insulin glargine in subsets of patients studied from IMAGINE-2 and IMAGINE-5.
“BIL is mechanistically different from current basal insulins. It has actually a hepato-preferential action, driven by its low effect on peripheral tissues,” said David Kendall, M.D., vice president, Medical Affairs, Lilly Diabetes. “Exactly what we’ve seen from the Phase III trials are unprecedented results in the basal insulin space: superior glycemic control along with much less nocturnal hypoglycemia and low weight gain, all of which are necessary to physicians and patients. We’re pleased to share these Phase III results along with the scientific community this week. ”
BIL Type 2 Clinical Data
In all three type 2 diabetes trials, BIL showed consistent superiority in reducing HbA1c levels from baseline to the primary endpoint compared to insulin glargine:1,2,3,5
- IMAGINE-2 (reductions of 1.6 percent vs. 1.3 percent at 52 weeks)1
- IMAGINE-4 (reductions of 1.7 percent vs. 1.five percent at 26 weeks)2
- IMAGINE-five (reductions of 0.82 percent vs. 0.29 percent at 26 weeks).3
More patients taking BIL reached the ADA’s recommended target HbA1c of much less compared to 7 percent compared to insulin glargine at the primary endpoint:
- IMAGINE-2: 58 percent vs. 43 percent at 52 weeks1
- IMAGINE-4: 63 percent vs. 53 percent at 26 weeks2
- IMAGINE-5: 73 percent vs. 52 percent at 26 weeks3
In another Phase III trial (IMAGINE-6), patients taking BIL went through higher reductions in HbA1c compared to those taking Neutral Protamine Hagedorn (NPH) insulin (1.7 percent vs. 1.4 percent). a lot more BIL patients additionally reached the ADA’s recommended target of much less compared to 7 percent (63.1 percent vs. 43.4 percent).5 A higher percentage of BIL-treated patients additionally reported much less nocturnal hypoglycemia compared to those on NPH.
Hepatic (liver) safety findings:
- In integrated analyses of type 2 diabetes clinical trials compared to glargine, a lot more patients taking BIL had a mean increase from baseline in the liver enzyme ALT at 52 weeks (mean difference between treatment groups: 7.4 IU/L). Additionally, a higher proportion of BIL patients had ALT levels higher compared to or equal to three times the upper limit of the normal range (ALT≥3X ULN) compared to insulin glargine (2.03 percent vs. 0.62 percent). No cases of severe drug-induced liver injury (Hy’s Law) occurred in these studies.
- IMAGINE-2 :
- ALT modification from baseline at 52 weeks: 4.1 IU/L vs. -2.0 IU/L
- ALT ≥3X ULN: 2.3 percent vs. 0.6 percent1
- ALT modification from baseline at 26 weeks: 7.6 IU/L vs. -0.6 IU/L
- ALT ≥3X ULN: 1.9 percent vs. 0.9 percent2
- ALT modification from baseline at 52 weeks: 8.3 IU/L vs. 0.4 IU/L
- ALT ≥3X ULN: 2.3 percent vs. 0.0 percent3
- IMAGINE-2 :
- In IMAGINE-6, a lot more patients taking BIL had a mean increase from baseline in the liver enzyme ALT at 52 weeks (mean difference between treatment groups: 7.4 IU/L). However, the proportion of BIL patients that had ALT levels higher compared to or equal to three times the upper limit of the normal range (ALT≥3X ULN) was similar to patients treated along with NPH insulin.
- In IMAGINE-2 and IMAGINE-5, liver fat was measured using magnetic resonance imaging (MRI) in a subset of patients. Results showed:
- In IMAGINE-2, liver fat did not modification from baseline in patients treated along with BIL, while patients taking insulin glargine went through a decrease in liver fat from 12.7 percent at baseline to 10.0 percent at 52 weeks. The mean difference between treatment groups at 52 weeks was 2.6 percent.1
- In IMAGINE-5, patients taking BIL went through an increase in liver fat from 10.4 percent at baseline to 14.8 percent at 52 weeks, while liver fat did not modification significantly in patients taking insulin glargine. The mean difference between treatment groups at 52 weeks was 5.3 percent.3
Non-hepatic safety findings:
- In IMAGINE-2, IMAGINE-4 and IMAGINE-five trials, triglycerides were better in patients treated along with BIL compared to insulin glargine. Rates of major edge cardiac events MACE+ (cardiovascular death, non-fatal stroke, non-fatal MI and hospitalization as a result of unstable angina) were similar between patients treated along with BIL and insulin glargine.1,2,3
- An analysis across all trials – including type 1—showed that the rates of major edge cardiovascular events among patients taking BIL and those taking insulin glargine or NPH insulin were similar, along with an observed hazard ratio below 1 and the upper limit of the 9five percent assurance interval below 1.4.
- Injection site reactions were a lot more common along with BIL compared to insulin glargine.1,2,3
About the Studies
IMAGINE-2 is a Phase III, randomized, 52-week, double-blind, treat-to-target study of BIL (n=1,003) compared to insulin glargine (n=535) in insulin-naïve patients along with type 2 diabetes. Patients in both groups had a baseline HbA1c of 8.five percent. Insulin therapy was taken alone or on a background of oral antihyperglycemic medication.1
IMAGINE-4 is a Phase III, randomized, 26-week, double-blind, treat-to-target study designed to compare BIL (n=691; baseline HbA1c: 8.4 percent) to insulin glargine (n=678; baseline HbA1c: 8.five percent) in combination along with mealtime insulin in patients along with type 2 diabetes.2
IMAGINE-five is a Phase III, 52-week, open-label, randomized, treat-to-target study designed to evaluate BIL (n=307) compared to insulin glargine (n=159) in patients along with type 2 diabetes already taking a basal insulin. Patients in both groups had a baseline HbA1c of 7.4 percent. Insulin was administered alone or in combination along with oral antihyperglycemic medications.3
IMAGINE-6 is a Phase III, 26-week, open-label, treat-to-target, randomized study designed to determine if BIL (n=428) was non-inferior to NPH insulin (n=213) in reducing HbA1c once added to pre-study oral agents. Patients in both groups had a baseline HbA1c of 8.five percent. Insulin was administered alone or in combination along with oral antihyperglycemic medications.5
About Basal Insulin Peglispro
Basal insulin peglispro (BIL), which was discovered and created in Lilly Research Laboratories, is currently in Phase III clinical trials and is being studied as a once-day-to-day basal insulin treatment for type 1 and type 2 diabetes. BIL is a hepato-preferential basal insulin. Its activity profile is derived from its low effect in peripheral tissue, making it a lot more similar to endogenous insulin compared to others exogenous insulins along with a conventional activity profile.
In the clinical trial program to date, consisting of a lot more compared to 6,000 patients, approximately 3,900 patients have actually been treated along with BIL. In the core Phase III clinical trial program – consisting of seven IMAGINE trials in patients along with type 1 and type 2 diabetes – superiority in HbA1c for BIL was seen in 5 trials conducted versus insulin glargine.
Approximately 29 million Americans6 and an estimated 387 million people global have actually type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 9five percent of all diabetes cases. Diabetes is a chronic disease that occurs once the physique either does not properly produce, or use, the hormone insulin.7
About Lilly Diabetes
Lilly has actually been a global leader in diabetes care since 1923, once we introduced the world’s initial commercial insulin. Today we are building upon this heritage by working to meet the diverse calls for of people along with diabetes and those that care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to offer real solutions—from medicines to support programs and more—we strive to make life much better for all those affected by diabetes around the world. For a lot more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring along with discovery to make life much better for people around the world. We were founded a lot more compared to a century ago by a man committed to developing high-quality medicines that meet real needs, and today we stay true to that mission in all our work. Across the globe, Lilly employees job to find and bring life-changing medicines to those that need them, improve the understanding and management of disease, and provide spine to communities through philanthropy and volunteerism. To learn a lot more Concerning Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
This press release contains forward-looking statements Concerning an investigational compound basal insulin peglispro, which is currently in development for the treatment of diabetes. It reflects Lilly’s current beliefs; however, as along with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no make sure that future study results and patient experience will certainly be consistent along with study findings to date or that basal insulin peglispro will certainly receive called for regulatory approvals or prove to be commercially successful. For further discussion of these and others risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed along with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
1 Davies M, Russell-Jones D, Selam J, et al. Basal Insulin Peglispro (BIL) is Superior to Insulin Glargine (GL) in Reducing HbA1c at 52 Wks in Insulin-Naïve T2D Patients (Pts) Treated along with Oral Antihyperglycemic Medications (OAMs): IMAGINE 2. Abstract 93-OR. Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 3 Buse J, Rodbard H, Serrano C, et al. Superior HbA1c Reduction along with Basal Insulin Peglispro (BIL) vs Insulin Glargine (GL) Alone or along with Oral Antihyperglycemic Medications (OAMs) in T2D Patients (Pts) Previously Treated along with Basal Insulin: IMAGINE 5. Abstract 984-P. Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 5 Grunberger G, Chen L, Rodriguez Á, et al. Basal Insulin Peglispro (BIL) Provides Clinically and Significantly much better HbA1c Control along with much less Nocturnal Hypoglycemia compared to NPH once Used in Combination along with Oral Agents in Insulin-Naïve T2D Patients (Pts): IMAGINE 6. Abstract 1004-P. Presented at 75th American Diabetes Association (ADA) Scientific Sessions; 7 Global Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: Global Diabetes Federation, 2014. http://www.idf.org/diabetesatlas/update-2014.
Refer to: Candace Johnson, email@example.com, (317) 755-9143
SOURCE Eli Lilly and Company