New data from Boehringer Ingelheim and Lilly showcase strength of Diabetes Alliance

New data for linagliptin, the dipeptidyl peptidase-4 (DPP-4) inhibitor approved in the U.S., E.U., Japan and other countries, will be presented at EASD. The Alliance has a robust, combined late-stage development programme in diabetes. Recent data are available for the investigational inhibitor of the sodium glucose co-transporter-2 (SGLT2), empagliflozin* as well as for the investigational novel basal insulin analogue LY2605541*, both of which are in late stage clinical development.

The abstracts to be presented at EASD include safety and efficacy data in various patient populations with T1D and T2D. Highlights of the data are:

• Linagliptin: Results from a large Phase III study evaluating the long-term safety and efficacy of linagliptin or placebo added on to basal insulin in patients inadequately controlled on basal insulin therapy** and three pooled analyses of Phase III data in T2D patient populations will be presented.

• Empagliflozin*: The Alliance will present Phase IIb safety and efficacy data, including effects on HbA1c, blood pressure and weight, for the SGLT2 inhibitor empagliflozin*.

• Novel basal insulin analogue, LY2605541*: Pre-clinical, Phase I and Phase II clinical trial data assessing the effects of the novel basal insulin analogue, LY2605541*, on glycaemic control and other measures in T1D and T2D patients will be presented.

Linagliptin Data

Clinical and pre-clinical abstracts on linagliptin will be presented at the meeting. Details of select presentations are as follows:

• Tuesday 2 October 2012, 10:45 AM – 12:15 PM, Oral Session: 01 Incretin based therapies
  Long-term safety and efficacy of linagliptin as add-on therapy to basal insulin in patients with type 2 diabetes: a 52-week randomised, placebo controlled trial **
  (Lead Author: H Yki-Järvinen) [Presentation 6]
  Effects of the DPP-4 inhibitor linagliptin on albuminuria in patients with type 2 diabetes and diabetic nephropathy
  (Lead Author: P.-H. Groop) [Presentation 36]
• Tuesday 2 October 2012, 12:30 PM – 1:30 PM, General Poster Session: 067 DPP-4 inhibitors I
  Safety and efficacy of linagliptin plus basal insulin combination therapy in a vulnerable population of elderly patients (aged ≥70 years) with type 2 diabetes**
  (Lead Author: HJ Woerle) [Poster No. 848]
  Safety and efficacy of linagliptin in elderly patients with type 2 diabetes: evidence from 1331 individuals aged ≥65 years
  (Lead Author: S Patel) [Poster No. 850]

 Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin), in the U.S. as Tradjenta™ (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.

Empagliflozin* Data

Pre-clinical and clinical data will be presented on empagliflozin*. Details on this presentation are as follows:

• Thursday 4 October 2012, 12:00 PM – 1:00 PM, General Poster Session 059 SGLT2 IV
  The sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin* lowers blood pressure independent of weight or HbA1c changes (Lead Author: T Hach) [Poster No. 770]

Novel Basal Insulin Analogue, LY2605541* Data

Details of select presentations for LY2605541* are as follows:

• Tuesday 2 October 2012,10:45 AM – 12:15 PM, Oral Session: 04 Insulin action in the liver
  Novel PEGylated basal insulin LY2605541* has a preferential hepatic effect on glucose metabolism (Lead Author: MC Moore) [Presentation 24]
• Tuesday 2 October 2012, 3:00 PM – 4:30 PM, General Poster Session: 07 What’s new in insulin therapy?
  LY2605541*: Leveraging hydrodynamic size to develop a novel basal insulin (Lead Author: JM Beals) [Presentation 42]
• Thursday 4 October 2012, 1:15 PM – 2:15 PM, General Poster Session: 078 Psychological aspects I
  Novel long-acting basal insulin analogue LY2605541* significantly reduces nocturnal hypoglycaemia and fear of hypoglycaemia compared to insulin glargine in patients with type 2 diabetes mellitus (Lead Author: B Curtis) [Poster No. 954]