Pivotal phase 3 data in people with type 1 and type 2 diabetes presented at the American Diabetes Association’s 79th Scientific Sessions
INDIANAPOLIS, IN, USA I June 9, 2019 I Two phase 3 studies show that Eli Lilly and Company’s (NYSE: LLY) ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog® (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog.1,2 Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day.3 URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. These data and several other studies were presented at the American Diabetes Association’s® 79th Scientific Sessions®.
The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal compared to Humalog.1,2
Hypoglycemia is the most common adverse reaction associated with insulin. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.1,2
“Many people taking mealtime insulin are not meeting their A1C goals while also experiencing high blood glucose levels after eating. This may create worry about their ability to achieve good control,” said Bruce Bode, MD, FACE, diabetes specialist at Atlanta Diabetes Associates.4 “The results from these two studies suggest that URLi may help control blood glucose after meals, as well as help people reach A1C goals.”
The PRONTO studies were designed as treat-to-target, which enables clinicians to determine differences in other important treatment effects – such as rates of hypoglycemia, post-meal glucose control and glucose time in range – at the same level of glycemic control. A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer (+43.6 minutes) time in range (71-180 mg/dL) during the day and similar time in range during the night compared to Humalog.3
Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also demonstrated URLi’s effect on post-meal blood glucose control. Results showed URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. URLi also showed lower blood glucose spikes after a test meal compared to the insulins tested, which was significant compared to Humalog and insulin aspart. Additionally, the early blood glucose profile with URLi closely matched that of participants without diabetes.5
“We’re developing URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes,” said Tom Hardy, MD, PhD, senior medical director at Lilly. “If approved, URLi will offer a new mealtime insulin option that, in clinical trials, showed similar A1C reductions to Humalog with significant improvements in post-meal blood glucose after a test meal.”
Lilly submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later this year.
About the PRONTO Studies
PRONTO-T1D and PRONTO-T2D were randomized, double-blind, controlled, treat-to-target comparisons of ultra rapid lispro (URLi) and Humalog (insulin lispro), both in combination with either insulin glargine or insulin degludec in adults with type 1 and type 2 diabetes, respectively. The primary objective of each study, conducted in 1,222 and 673 participants, respectively, was to evaluate whether URLi is non-inferior to Humalog in reducing A1C from baseline after 26 weeks of treatment. Key endpoints were adjusted for multiple testing, including the comparisons of one and two hour post-prandial glucose and A1C superiority.
About Diabetes
Approximately 30 million Americans6 and an estimated 425 million adults worldwide have diabetes.7 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.6 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes. We offer a wide range of therapies and a continued determination to provide real solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
References:
- Klaff L., Dachuang C., Dellva M.A., et al. Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control vs. Humalog (Lispro) in T1D: PRONTO-T1D Study. Abstract 144-OR. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Blevins T., Zhang O., Frias J.P., et al. Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control vs. Humalog (Lispro) in Patients with Type 2 Diabetes (T2D): PRONTO-T2D. Abstract 145-OR. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Bode B., Dachuang C., Rong L., et al. Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control and Time in Range (TIR) in T1D Compared to Humalog (Lispro): PRONTO-T1D Continuous Glucose Monitoring (CGM) substudy. Abstract 1089-P. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Chaplin S. Summary of the National Diabetes Audit 2015-16 Report. Prescriber; published online April 2017. Available at: https://onlinelibrary.wiley.com/doi/epdf/10.1002/psb.1559. Accessed January 06.
- Heise T., Linnebjerg H., Dachuang C., et al. Ultra Rapid Lispro (URLi) Lowers Postprandial Glucose (PPG) and More Closely Matches Normal Physiological Glucose Response Compared with Other Rapid Insulin Analogs. Abstract 1112-P. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Available at: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. November 2017.
- International Diabetes Federation. IDF Diabetes Atlas, 8th edn, 2017. Available at: http://www.diabetesatlas.org/. November 2017.
SOURCE: Eli Lilly
Post Views: 162
Pivotal phase 3 data in people with type 1 and type 2 diabetes presented at the American Diabetes Association’s 79th Scientific Sessions
INDIANAPOLIS, IN, USA I June 9, 2019 I Two phase 3 studies show that Eli Lilly and Company’s (NYSE: LLY) ultra rapid lispro (URLi) provided non-inferior A1C reductions compared to Humalog® (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog.1,2 Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day.3 URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels. These data and several other studies were presented at the American Diabetes Association’s® 79th Scientific Sessions®.
The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal compared to Humalog.1,2
Hypoglycemia is the most common adverse reaction associated with insulin. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.1,2
“Many people taking mealtime insulin are not meeting their A1C goals while also experiencing high blood glucose levels after eating. This may create worry about their ability to achieve good control,” said Bruce Bode, MD, FACE, diabetes specialist at Atlanta Diabetes Associates.4 “The results from these two studies suggest that URLi may help control blood glucose after meals, as well as help people reach A1C goals.”
The PRONTO studies were designed as treat-to-target, which enables clinicians to determine differences in other important treatment effects – such as rates of hypoglycemia, post-meal glucose control and glucose time in range – at the same level of glycemic control. A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer (+43.6 minutes) time in range (71-180 mg/dL) during the day and similar time in range during the night compared to Humalog.3
Data from a phase 1 clinical pharmacology study in people with type 1 diabetes also demonstrated URLi’s effect on post-meal blood glucose control. Results showed URLi was absorbed significantly faster into the blood stream compared to Humalog, insulin aspart and fast-acting insulin aspart. URLi also showed lower blood glucose spikes after a test meal compared to the insulins tested, which was significant compared to Humalog and insulin aspart. Additionally, the early blood glucose profile with URLi closely matched that of participants without diabetes.5
“We’re developing URLi to provide a mealtime insulin option that more closely mirrors the way insulin works in people without diabetes,” said Tom Hardy, MD, PhD, senior medical director at Lilly. “If approved, URLi will offer a new mealtime insulin option that, in clinical trials, showed similar A1C reductions to Humalog with significant improvements in post-meal blood glucose after a test meal.”
Lilly submitted applications for URLi with regulatory authorities in Europe and Japan and plans to submit in the U.S. later this year.
About the PRONTO Studies
PRONTO-T1D and PRONTO-T2D were randomized, double-blind, controlled, treat-to-target comparisons of ultra rapid lispro (URLi) and Humalog (insulin lispro), both in combination with either insulin glargine or insulin degludec in adults with type 1 and type 2 diabetes, respectively. The primary objective of each study, conducted in 1,222 and 673 participants, respectively, was to evaluate whether URLi is non-inferior to Humalog in reducing A1C from baseline after 26 weeks of treatment. Key endpoints were adjusted for multiple testing, including the comparisons of one and two hour post-prandial glucose and A1C superiority.
About Diabetes
Approximately 30 million Americans6 and an estimated 425 million adults worldwide have diabetes.7 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.6 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes. We offer a wide range of therapies and a continued determination to provide real solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
References:
- Klaff L., Dachuang C., Dellva M.A., et al. Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control vs. Humalog (Lispro) in T1D: PRONTO-T1D Study. Abstract 144-OR. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Blevins T., Zhang O., Frias J.P., et al. Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control vs. Humalog (Lispro) in Patients with Type 2 Diabetes (T2D): PRONTO-T2D. Abstract 145-OR. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Bode B., Dachuang C., Rong L., et al. Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control and Time in Range (TIR) in T1D Compared to Humalog (Lispro): PRONTO-T1D Continuous Glucose Monitoring (CGM) substudy. Abstract 1089-P. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Chaplin S. Summary of the National Diabetes Audit 2015-16 Report. Prescriber; published online April 2017. Available at: https://onlinelibrary.wiley.com/doi/epdf/10.1002/psb.1559. Accessed January 06.
- Heise T., Linnebjerg H., Dachuang C., et al. Ultra Rapid Lispro (URLi) Lowers Postprandial Glucose (PPG) and More Closely Matches Normal Physiological Glucose Response Compared with Other Rapid Insulin Analogs. Abstract 1112-P. Presented at the American Diabetes Association’s 79th Scientific Sessions; June 7-11, San Francisco, CA.
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Available at: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. November 2017.
- International Diabetes Federation. IDF Diabetes Atlas, 8th edn, 2017. Available at: http://www.diabetesatlas.org/. November 2017.
SOURCE: Eli Lilly
Post Views: 162
