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AstraZeneca And Bristol-Myers Squibb To Present New Data At American Diabetes Association 73rd Scientific Sessions®

AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that 33 abstracts on the companies’ research in diabetes have been accepted for presentation at the 73rd Scientific Sessions ® of the American Diabetes Association (ADA) in Chicago, June 21-25. The data include studies from five marketed products as well as dapagliflozin, an investigational compound in the U.S., currently approved for use in the European Union, Australia, New Zealand and Mexico. In addition to blood glucose control, studies presented at the meeting examine impact on cardiovascular risk factors such as weight and blood pressure, which are important to overall disease management in people with diabetes.

“The AstraZeneca and Bristol-Myers Squibb Alliance will present data on a broad, versatile portfolio including Onglyza, Kombiglyze XR, Symlin, Byetta and Bydureon, as well as the investigational compound dapagliflozin,” said John Yee, MD, MPH, vice president, head of Medical Affairs, AstraZeneca/Bristol-Myers Squibb U.S. Diabetes Alliance. “The diversity of data reflects our joint commitment to researching and delivering innovative medicines and treatment options to help patients overcome the burdens of diabetes.”

Key presentations include:
  • The first presentation of Phase IIa pilot data exploring the use of dapagliflozin in adult patients with type 1 diabetes (late-breaking poster, 70-LB)
  • Four-year data examining the durability of dapagliflozin vs. glipizide as add-on therapies in patients with type 2 diabetes inadequately controlled on metformin (late-breaking poster, 62-LB)
  • Study evaluating the efficacy and tolerability of saxagliptin in patients with type 2 diabetes and a history of cardiovascular disease (poster 1174-P)
  • Three-year data from a study examining the effect of exenatide once weekly on sustained glycemic control and weight compared with insulin glargine (oral presentation, 67-OR)
  • Phase IV study examining glycemic control, weight, and hypoglycemia with exenatide compared to mealtime administration of rapid-acting analog insulin (oral presentation, 70-OR)

The complete list of AstraZeneca and Bristol-Myers Squibb data presentations is below and can also be accessed on the ADA website.
Presentations     Date/Time

All times are CDT
Bydureon ® (exenatide extended-release for injectable suspension) and Byetta ® (exenatide) Clinical Data
Exenatide Once Weekly: Data on Glycemic Control and Weight Through 3 Years Compared with Insulin Glargine (oral presentation, 67-OR)     June 22, 8:30 a.m. – 8:45 a.m.
Exenatide BID vs Insulin Lispro TID Added to Titrated Insulin Glargine QD in Metformin-Treated T2DM Patients Impact on Glycemic Control, Weight and Hypoglycemia: the 4B Study (oral presentation, 70-OR)     June 22, 9:15 a.m – 9:30 a.m.
Efficacy and Tolerability of Exenatide Twice Daily in Asian vs White Patients with T2DM (poster 1035-P)     June 22, 11:30 a.m. – 1:30 p.m
Quantification of the Benefit-Risk Relationship Between Glycemic Control and Hypoglycemia: A Comparison of Exenatide Once Weekly with Titrated Insulin Glargine (poster 1034-P)     June 22, 11:30 a.m. – 1:30 p.m
Affect of Relative β-cell Function on A1C and Fasting Glucose with Exenatide in T2DM Patients (poster 1023-P)     June 22, 11:30 a.m. – 1:30 p.m
Add-on Treatment with Exenatide Once Weekly vs Daily Basal Insulin in Patients with A1C ≥8.5% (poster 1018-P)     June 22, 11:30 a.m. – 1:30 p.m
Exenatide Once Weekly: Association Between Weight Response, Glycemic Control, and Markers of Cardiovascular Risk (poster 1182-P)     June 23, 1 – 2 p.m. (Guided poster tour)
Onglyza ® (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCl extended-release tablets) Clinical Data
Saxagliptin (SAXA) as Add-on to Metformin (MET) + Sulfonylurea (SU): Outcomes Stratified by Baseline A1C and Patient Characteristics (poster 1134-P)     June 23, Noon – 2 p.m.
Efficacy and Tolerability of Saxagliptin (SAXA) in Patients With Type 2 Diabetes Mellitus (T2DM) and a History of Cardiovascular Disease (CVD) (poster 1174-P)     June 23, Noon – 2 p.m.
Efficacy and Safety of Saxagliptin (SAXA) in Patients With Type 2 Diabetes (T2DM) and High Framingham 10-Year Cardiovascular (CV) Risk (poster 1135-P)     June 23, Noon – 2 p.m.
Early Onset of Increased Hypoglycemic Incidence With Glipizide (GLIP) vs Saxagliptin (SAXA) in Type 2 Diabetes Patients on Metformin (poster 1151-P)     June 23, Noon – 2 p.m.
Efficacy and Safety of Saxagliptin (SAXA) in Patients With Type 2 Diabetes Receiving Concomitant Statin Therapy (poster 1133-P)     June 23, Noon – 2 p.m.
Efficacy and Safety of Saxagliptin (SAXA) in Adult Diabetes Patients With GAD Antibodies (poster 1107-P)     June 23, Noon – 2 p.m.
Symlin ® (pramlintide acetate) Injection Clinical Data
Effects of Pramlintide on A1C, Weight, and Hypoglycemia in Patients with Type 1 or Type 2 Diabetes: Subgroup Analysis by Duration of Diabetes (poster 1036-P)     June 22, 11:30 a.m. – 1:30 p.m.
Health Economics Outcomes Research Data
Long-Term Cardiovascular Outcomes with Exenatide Twice Daily Compared to Insulin: A Retrospective Observational Study (poster 1420-P)     June 23, Noon – 2 p.m.
Functional Status of Patients with Type 2 Diabetes Mellitus: Is it the Diagnosis or Underlying Risk Factors Promoting Ill Health? (poster 1481-P)     June 23, Noon – 2 p.m.

Association of ≥5% Weight Loss and Self-Reported Adherence with 6-month Glycemic Control in Type 2 Diabetes Mellitus (T2DM): the DELTA Study (poster 1227-P)
    June 23, Noon – 2 p.m.
Quality of Care for Type 2 Diabetes Mellitus Patients in Dubai: A Retrospective Cohort Study (poster 1286-P)     June 23, Noon – 2 p.m.
Understanding Clinical Inertia: Are Patient or Provider Characteristics Predictive of Glycemic Control? (poster 1222-P)     June 22, 12:30 p.m. – 1:30 p.m. (Guided poster tour)
Real-World Cardiovascular Event Rates among High-risk Adults with Type 2 Diabetes Mellitus (poster 1408-P)     June 23, Noon – 2 p.m.
High Mortality and Cardiovascular Event Rates within Type 2 Diabetes Mellitus (T2DM) Patients with Established Cardiovascular Disease (CVD) or CVD Risk Factors in a Large US Database (poster 1426-P)     June 23, Noon – 2 p.m.
Cardiovascular Event Rates in a Type 2 Diabetes Population in a Real-World UK Setting: A Large Database Study Using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) (poster 1414-P)     June 23, Noon – 2 p.m.
Resource Use of Type 2 Diabetes Mellitus Patients Following Initiation with Saxagliptin or Sitagliptin (poster 1260-P)     June 23, Noon – 2 p.m.
Combination Therapy With Metformin Plus Sulfonylureas Versus Metformin Plus DPP-4 Inhibitors and Risk of All-Cause Mortality (late-breaking poster, 112-LB)     June 23, Noon – 2 p.m.
Investigational Dapagliflozin Clinical Data
Exploring the Potential of Dapagliflozin in Type 1 Diabetes: Phase 2a Pilot Study (late-breaking poster, 70-LB)    

June 23, Noon – 2 p.m.
Durability of Dapagliflozin vs Glipizide as Add-on Therapies in T2DM Inadequately Controlled on Metformin: 4-year Data (late-breaking poster, 62-LB)     June 23, Noon – 2 p.m.
Perspectives on T2DM from Clinicians and from People with T2DM in China: the EXPLORE Global Survey (poster 849-P)     June 22, 11:30 a.m. – 1:30 p.m.
Dapagliflozin Effects on the Lipid Profile of Patients with Type 2 Diabetes Mellitus (poster 1188-P)     June 23, Noon – 1 p.m. (Guided poster tour)
Efficacy and Safety of Dapagliflozin Monotherapy in Japanese Patients with Type 2 Diabetes Inadequately Controlled with Diet and Exercise (poster 1163-P)     June 23, Noon – 2 p.m.
Effect of Dapagliflozin as Part of Triple Combination Therapy on HbA1c and Body Weight in Patients with Type 2 Diabetes (poster 1176-P)     June 23, Noon – 2 p.m.
Dapagliflozin as Monotherapy in Drug-Naïve Asian Patients with T2DM Inadequately Controlled on Diet and Exercise (poster 1105-P)     June 23, Noon – 2 p.m.
Response to Dapagliflozin by Baseline HbA1c in Head-to-Head Comparisons (poster 1116-P)     June 23, Noon – 2 p.m.

Effect of Add-On Dapagliflozin on Frequency of Combined HbA1c and Weight Reduction Versus Add-On Glipizide in Patients with Type 2 Diabetes Inadequately Controlled on Metformin (oral presentation, 236-OR)
    June 23, 4:30 p.m. – 6:30 p.m.

INDICATION and IMPORTANT SAFETY INFORMATION for BYDUREON ® (exenatide extended-release for injectable suspension)

Indication and Important Limitations of Use for BYDUREON:

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

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