Boehringer Ingelheim and Lilly to feature 30 presentations on type 1 and type 2 diabetes

Together, the Alliance will present data on a number of topics, including, but not limited to: efficacy and safety data in various populations of patients with diabetes, including patients on monotherapy and add on therapy, patients with comorbidities, patients with type 1 and type 2 diabetes (T1D and T2D), and efficacy and safety data in comparison to other diabetes medications. Highlights of this data, which demonstrates the Alliance’s commitment to diabetes, includes:

• Novel basal insulin*: The Alliance will present pre-clinical, Phase I and Phase II clinical trial data for their investigational novel basal insulin analogue, LY2605541*. The Phase II data is further defined below.
• Empagliflozin*: 78-weeks safety and efficacy results for the investigational sodium glucose co-transporter−2 (SGLT−2) inhibitor empagliflozin as monotherapy or add-on to metformin.
• Linagliptin: Results from a randomised phase III clinical trial with linagliptin alone or in combination with other diabetes therapies as well as a post-hoc analysis evaluating the clinical effect of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin on albuminuria in adults with T2D and high risk of declining renal function will be presented.
  – Linagliptin (5 mg, once daily) is marketed in the U.S. as Tradjenta™ (linagliptin), in Europe as Trajenta™ (linagliptin), and in other global markets as a once-daily tablet that is used along with diet and exercise either as monotherapy or in combination with other treatments, such as metformin or metformin + sulphonylurea, to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with T1D or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). Linagliptin is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.

Novel Basal Insulin Analog (LY2605541*) Data

Of the 10 abstracts to be presented for LY2605541, four are from two Phase II studies in people with T1D and T2D. These presentations are as follows:

• Saturday, June 9, 11:30 AM – 1:30 PM, General Poster Session
  – Contrasting Weight Changes with LY2605541*, a Novel Long-Acting Insulin, and Insulin Glargine Despite Similar Improved Glycemic Control in T1D and T2D (Lead Author: S. Jacober) [Poster No. 1023-P]
  – Better Glycaemic Control and Weight Loss with the Novel Long-Acting Basal Insulin LY2605541* Compared with Insulin Glargine in Patients with Type 1 Diabetes (Lead Author: J. Rosenstock) [Poster No. 1026-P]
• Monday, June 11, 4:30 – 6:30 PM, Oral Session: Insulin Analogs
  – The Novel Long-Acting Insulin LY2605541* Is Superior to Insulin Glargine in Lowering Intra-Day Glucose Variability and Hypoglycemia Event Rate from Continuous Glucose Monitoring (CGM) in Patients with Type 2 Diabetes (Lead Author: R. Bergenstal) [Presentation 346-OR]
  – Reduced Nocturnal Hypoglycemia and Weight Loss with Novel Long-Acting Basal Insulin LY2605541* Compared with Insulin Glargine in Patients with Type 2 Diabetes (Lead Author: R. Bergenstal) [Presentation 347-OR]

Empagliflozin* Data

Among the six abstracts for empagliflozin*, late breaking data from a trial investigating the safety and efficacy of empagliflozin* as monotherapy or in combination with metformin in T2D will be presented. Details on this and additional empagliflozin* presentations are as follows:

• Saturday, June 9, 11:30 AM – 1:30 PM, General Poster Session
  – The effect of hepatic impairment on the pharmacokinetics, safety and tolerability of empagliflozin*, a potent sodium glucose co-transporter-2 inhibitor (Lead Author: S. Macha) [Poster No. 1067-P]
• Sunday, June 10, 12:00 PM – 2:00 PM, General Poster Session
  – Safety and efficacy of empagliflozin* as monotherapy or add-on to metformin in a 78-week open-label extension study in patients with type 2 diabetes (Lead Author: HJ Woerle) [Poster No. 49-LB]

Linagliptin Data

A total of 14 clinical and preclinical abstracts regarding linagliptin will be presented at the meeting. Details of select presentations are as follows:

• Saturday, June 9, 11:30 AM – 13:30 PM, General Poster Session
  – Linagliptin lowers albuminuria on top of recommended standard treatment for diabetic nephropathy (Lead Author: P-H. Groop) [Poster No. 953-P] Also Guided Audio Tour: 13:00 – 14:00, Monday, 11 June
  – Efficacy and safety of linagliptin as add-on therapy to basal insulin in patients with type 2 diabetes (Lead Author: H. Yki-Jarvinen) [Poster No. 999-P]
  – Linagliptin is more effective than glimepiride at achieving a composite outcome of A1C target with no hypoglycemia and no weight gain over 2 years in mildly hyperglycaemic type 2 diabetes patients on metformin (Lead Author: B. Gallwitz) [Poster No. 1044-P]

About Diabetes

An estimated 366 million people worldwide have T1D and T2D. 1 T2D is the most common type, accounting for an estimated 90 to 95% of all diabetes cases. 2 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin. 3

References

1. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: April 11, 2012.
2. Centers for Disease Control and Prevention.Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human. Services, Centers for Disease Control and Prevention, 2011.
3. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 11, 2012.

*Novel basal insulin LY2605541 and empagliflozin are investigational compounds. Their safety and efficacy have not yet been fully established.