Efficacy and safety data on linagliptin and investigational compound empagliflozin* in various diabetes subpopulations presented by Boehringer Ingelheim and Eli Lilly and Company

Sep 18 2013

Boehringer Ingelheim and Eli Lilly and Company today announced they will feature five oral and 12 poster presentations for linagliptin and the investigational compound empagliflozin* at the 49^th Annual Meeting of the European Association for the Study of Diabetes (EASD) which will take place in Barcelona, from 23 – 27 September. The presentations will add to the already existing body of data on safety and efficacy of these two compounds. 

Empagliflozin Data

A total of eight clinical and pre-clinical abstracts for the investigational agent empagliflozin will be presented. Empagliflozin is a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs and is being investigated for the reduction of blood glucose levels in adults with Type 2 Diabetes (T2D).

Details of clinical empagliflozin presentations and published abstracts are as follows:¹

Tuesday, 24 September, 12:30–13:30 CET, General Poster Session

• Empagliflozin as Add-on to Basal Insulin for 78 Weeks Improves Glycemic Control and Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM) (Presenting Author: J. Rosenstock) [Poster No. 931]
• Safety and Efficacy of Empagliflozin Monotherapy in a 52-Week Study in Japanese Patients with Type 2 Diabetes Mellitus (Presenting Author: H. J. Woerle) [Poster No. 930]
• Metabolic Response to Sodium Glucose Transporter 2 (SGLT2) Inhibition with Empagliflozin in Patients with Type 2 Diabetes (T2D) (Presenting Author: E. Ferrannini) [Poster No. 932]

Tuesday, 24 September, 13:45–14:45 CET, General Poster Session

• Empagliflozin Improves Blood Pressure in Patients with Type 2 Diabetes (T2DM) and Hypertension (Presenting Author: I. Tikkanen) [Poster No. 942]
• Empagliflozin Improved Glycemic Parameters and Cardiovascular Risk Factors in Patients with Type 2 Diabetes (T2DM): Pooled Data from Four Pivotal Phase III Trials (Presenting Author: T. Hach) [Poster No. 943]
• Design of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus  (Presenting Author: S. E. Inzucchi) [Poster No. 944]

Wednesday, 25 September, 12:30–13:30 CET, General Poster Session

• Empagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) and Stage 3A, 3B and 4 Chronic Kidney Disease (CKD) (Presenting Author: A. Mithal) [Poster No. 952]

Thursday, 26 September, 15:00 – 16:30 CET, Oral Presentation

• The Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitor Empagliflozin Improves Glycemic Control in Patients with Type 1 Diabetes: a Single-Arm Clinical Trial (Presenting Author: B. A. Perkins) [Oral Presentation No. 183]

* Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

Linagliptin Data

A total of nine clinical and pre-clinical abstracts for linagliptin will also be presented. Linagliptin is an inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4), which breaks down the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) that are involved with regulating blood glucose.²

Details of all clinical presentations and published abstracts are as follows:¹

Wednesday, 25 September, 10:45 – 12:15 CET, Oral Presentation

• Baseline Characteristics of Participants Enrolled in the Cardiovascular Outcome Study of Linagliptin versus Glimepiride in Early Type 2 Diabetes (CAROLINA) (Presenting Author: J. Rosenstock) [Oral Presentation No. 73]

Wednesday, 25 September, 12:30 – 13:30 CET, General Poster Session

• Efficacy and Safety of Linagliptin as Add-On Therapy to Basal Insulin and Metformin in Patients with Type 2 Diabetes (Presenting Author: S. Durán-Garcia) [Poster No. 892]

Wednesday, 25 September, 15:00 – 16:30 CET, Oral Presentation

• Cardiovascular (CV) Safety of Linagliptin in Patients with Type 2 Diabetes (T2D): A Pooled Comprehensive Analysis of Prospectively Adjudicated CV Events in Phase 3 Studies (Presenting Author: O. E. Johansen) [Oral Presentation No. 112]
• Linagliptin and the Angiotensin II Receptor Blocker Telmisartan Show Comparable Efficacy but Different Renoprotective Pathways in Rats with 5/6 Nephrectomy (Presenting Author: B. Hocher) [Oral Presentation No. 143]

Thursday, 26 September, 10:45 – 12:15 CET, Oral Presentation

• Insights into the Mechanism of Action of Linagliptin in Reducing Ischaemic Brain Damage Following Stroke in Diabetic and Non-Diabetic Mice (Presenting Author: V. Darsalia) [Oral Presentation No. 152]

Thursday, 26 September, 12:30 – 13:30 CET, General Poster Session

• Renal Safety and Outcomes with Linagliptin: Meta-Analysis of Individual Data for 5466 Patients with Type 2 Diabetes (Presenting Author: M. von Eynatten) [Poster No. 913]
• Linagliptin versus Placebo followed by Glimepiride in Type 2 Diabetes Patients with Moderate to Severe Renal Impairment (Presenting Author: P-H. Groop) [Poster No. 914]

Thursday, 26 September, 13:45 – 14:45 CET, General Poster Session

• Safety and Tolerability of Linagliptin in 7400 Patients with Type 2 Diabetes: A Pooled Comprehensive Analysis of Prospective Safety Reporting in Placebo-Controlled Studies (Presenting Author: M. Lehrke) [Poster No. 986]
• Renal Safety of Linagliptin in Elderly Patients with Type 2 Diabetes: Analysis of Pooled Patient Data From 7 Phase 3 Clinical Trials (Presenting Author: A. H. Barnett) [Poster No. 926]

Linagliptin, which is marketed as Trajenta^® 5mg tablets in Europe, is a once-daily tablet used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). Linagliptin is the only approved DPP-4 inhibitor that does not require dose adjustments regardless of renal or hepatic function.

Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com