AstraZeneca to highlight scientific advancements across its diabetes portfolio at the American Diabetes Association 76th Scientific Sessions

  • More than 60 accepted abstracts advancing the understanding of type 2 diabetes treatment and management of its multiple comorbidities
  • 21 abstracts on dapagliflozin, including an investigation of its effects on cardiovascular risk factors in type 2 diabetes with varying degrees of renal function and insights on its use in a real-world setting
  • 18 abstracts on exenatide, including its effect on glycemic fluctuations in type 2 diabetes and investigating its use with dapagliflozin in patients with non-diabetic obesity
  • 10 abstracts on new investigational compounds and notable late-breakers exploring their effects on multiple comorbidities and risk factors beyond glycemic control

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that more than 60 abstracts reporting results of the company’s research and development in diabetes have been accepted at the 76th Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, June 10-14, 2016.

Presentations include data evaluating FARXIGA® (dapagliflozin), BYDUREON® (exenatide extended-release), ONGLYZA® (saxagliptin) and BYETTA® (exenatide). Late-breaking data will also be presented, including investigational data on the effect of MEDI0382, a novel dual-agonist of the glucagon-like peptide 1 (GLP-1) and glucagon receptors on glycemic control and weight, and effect of MEDI4166, a novel fusion molecule of an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody and a GLP-1 analog on glucose control and cholesterol.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: “The breadth of our scientific data at ADA illustrates our ‘whole patient’ approach to diabetes research, where the ultimate goal is to achieve patient outcomes beyond glycemic control with a strong focus on delaying cardiovascular and chronic kidney disease complications.”   

The studies to be presented evaluate the management of multiple risk factors associated with type 2 diabetes, therapeutic durability and suboptimal glycemic control, early-stage research and development, safety and efficacy of combination therapies, and advances in diabetes care and global treatment patterns.

Robert Henry, MD, Chief, VA Endocrinology & Metabolism, Professor of Medicine, UC San Diego School of Medicine, said: “AstraZeneca’s strong global collaborations with health experts, patient advocates and policymakers have established it as a leader in transforming the management and treatment of diabetes. At ADA, the company will present a wealth of scientific knowledge generated with these partners that examines the interrelated nature of diabetes and its comorbidities, and explore novel, early approaches to treatment.”

Notable clinical and pre-clinical data being presented across areas of focus for AstraZeneca and MedImmune include:

Data evaluating the effect of dapagliflozin and exenatide on risk factors in patients with type 2 diabetes

  • Effects of Dapagliflozin on Cardiovascular Risk Factors at Varying Degrees of Renal Function (Poster 1095-P, Saturday June 11, 12:30 pm CDT)1
  • Safety and Efficacy of Dapagliflozin in Combination with Potassium-Sparing Agents (Poster 1094-P, Saturday June 11, 12:30 pm CDT)2
  • Baseline Characteristics of Patients Enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) (Poster 1039-P, Saturday June 11, 11:30 am CDT)3

Studies assessing the long-term effect and durability of AstraZeneca diabetes treatments on glycemic control

  • Effects of Dapagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, on 24-hour Glycemic Control in Patients with Type 2 Diabetes (Poster 1185-P, Sunday June 12, 12:00 pm CDT)4
  • Effect of Exenatide Once-Weekly on Glycemic Fluctuations in Patients with Type 2 Diabetes (Poster 1014-P, Sunday June 12, 12:00 pm CDT)5
  • DURATION-1 Extension in Patients with Type 2 Diabetes: Efficacy and Tolerability of Exenatide Once-Weekly Over 7 Years (Poster 1041-P, Saturday June 11, 11:30 am CDT)6
  • Time to Treatment Intensification and its Association with Subsequent Glycemic Control Among Patients with Type 2 Diabetes (Poster 1218-P, Saturday June 11, 12:30 pm CDT)7

Early-stage research and development evaluating novel approaches to diabetes and associated metabolic conditions

  • MEDI4166 A PCSK9 Ab-GLP-1 Fusion Molecule: Impact on Antidiabetic and Antihyperlipidemic Effects in Rodents and Non-human Primates (Late-Breaker LB-35, Sunday June 12, 12:00 pm CDT)8
  • Effect of a Dual GLP-1/Glucagon Receptor Agonist on Steatosis and Indices of Non-Alcoholic Steatosis (NASH) Compared to GLP-1 Receptor and FXR Agonists in a Mouse Model of NASH (Oral 71-OR, Saturday June 11, 8:30 am CDT)9
  • MEDI0382, Effects of a GLP-1/Glucagon Dual Agonist on Safety/Tolerability Endpoints in a Single Dose Healthy Volunteer Study (Late-Breaker LB-107, Sunday June 12, 12:00 pm CDT)10
  • Acute metabolic effects of MEDI0382, a GLP-1/Glucagon Dual Agonist, in Wild Type and GLP-1 Receptor Knock-Out (GLP-1RKO) Mice (Oral 134-OR, Saturday June 11, 1:45 pm CDT)11

Real-world evidence to help drive insights into treatment patterns globally

  • Advances in Diabetes Care 1996 to 2012: A Great Investment (Oral 350-OR, Monday June 13, 4:30 pm CDT)12
  • Real-World Clinical Outcomes Among Exenatide Once-Weekly Initiators Compared to Matched Initiators of Basal Insulin (Poster-1056-P, Saturday June 11, 11:30 am CDT)13
  • Suboptimal Glycemic control in Patients with Type 2 Diabetes: Retrospective Data from 22,272 Individuals (Poster 1558-P, Sunday June 12, 12:00 pm CDT)14

The complete list of AstraZeneca data presentations can be accessed on the ADA website here.

Indication and Limitations of Use for FARXIGA® (dapagliflozin)
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

FARXIGA is not indicated for weight loss or the treatment of cardiovascular risk factors.

Important Safety Information For FARXIGA

Contraindications

  • History of a serious hypersensitivity reaction to FARXIGA
  • Severe renal impairment, end stage renal disease, or patients on dialysis

Warnings and Precautions

  • Hypotension: FARXIGA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating FARXIGA, particularly in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating FARXIGA in patients with one or more of these characteristics, assess and correct volume status. After initiating therapy, monitor for signs and symptoms of hypotension.
  • Ketoacidosis has been reported in patients with type 1 and type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue FARXIGA, evaluate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
  • Impairment in Renal Function: FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating FARXIGA. Before initiating FARXIGA, evaluate renal function and monitor periodically thereafter. Discontinue FARXIGA when eGFR is persistently <60 mL/min/1.73 m2.
  • Urosepsis and Pyelonephritis: Serious urinary tract infections have been reported with SGLT2 inhibitors, including FARXIGA. SGLT2 inhibitors increase the risk for urinary tract infections. Evaluate for signs and symptoms of urinary tract infections and treat promptly.
  • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. FARXIGA can increase the risk of hypoglycemia when combined with these agents. Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA.
  • Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic infections were more likely to develop genital mycotic infections. Monitor and treat appropriately.
  • Increases in Low-Density Lipoprotein Cholesterol (LDL-C) occur with FARXIGA. After initiating FARXIGA, monitor LDL-C and treat per standard of care.
  • Bladder cancer: Across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 0.17% of FARXIGA-treated patients and 0.03% of placebo/comparator-treated patients. After excluding patients in whom exposure to study drug was <1 year at the time of diagnosis of bladder cancer, there were 4 cases with FARXIGA and no cases with placebo/comparator. Bladder cancer risk factors and hematuria (a potential indicator of pre-existing tumors) were balanced between treatment arms at baseline. There were too few cases to determine whether the emergence of these events is related to FARXIGA.

There are insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a prior history of bladder cancer.

  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA or any other antidiabetic drug.

Adverse Reactions

  • In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

Use in Specific Populations

  • Pregnant Women: There are no adequate and well-controlled studies of FARXIGA in pregnant women. Consider appropriate alternative therapies, especially during the second and third trimesters.
  • Nursing Mothers: It is not known whether FARXIGA is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from FARXIGA, discontinue nursing or discontinue FARXIGA.
  • Geriatric Use: A higher proportion of patients ≥65 years treated with FARXIGA had adverse reactions related to volume depletion and renal impairment or failure compared to patients treated with placebo. No FARXIGA dose change is recommended based on age.

Please click here for US Full Prescribing Information and Medication Guide for FARXIGA.

Indication and Important Limitations of Use for BYDUREON® (exenatide extended-release) for injectable suspension

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

  • BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans. Prescribe only to patients for whom potential benefits are considered to outweigh potential risk.
  • Not a substitute for insulin, should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and cannot be recommended for use with insulin.
  • BYDUREON and BYETTA® (exenatide) injection both contain the same active ingredient, exenatide, and should not be used together.
  • Exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYDUREON; consider other antidiabetic therapies for these patients.
  • BYDUREON is not indicated for weight loss.


Important Safety Information for BYDUREON

WARNING: RISK OF THYROID C-CELL TUMORS

  • Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.
  • BYDUREON is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of BYDUREON and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON.

Contraindications

  • Patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Patients with prior serious hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions
•    Pancreatitis: Based on postmarketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation of BYDUREON, observe patients carefully for pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYDUREON should be discontinued promptly and should not be restarted if pancreatitis is confirmed.

  • Increased Risk of Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Consider reducing the insulin secretagogues (e.g., sulfonylureas) or insulin dose to reduce the risk of hypoglycemia.
  • Renal Impairment: Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or moderate renal failure. Postmarketing reports of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
  • Gastrointestinal Disease: Because exenatide is commonly associated with gastrointestinal adverse reactions, BYDUREON is not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
  • Immunogenicity: Patients may develop antibodies to exenatide. In 5 registration trials, attenuated glycemic response was associated in 6% of BYDUREON-treated patients with antibody formation. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
  • Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON and other suspect medications and promptly seek medical advice.
  • Injection-Site Reactions: Postmarketing reports of serious injection-site reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, with the use of BYDUREON.
  • Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug.

Adverse Reactions

  • The most common (≥5%) adverse reactions reported in BYDUREON-treated patients and occurring more frequently than comparator in clinical trials were nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%).

Drug Interactions

  • Oral Medications: BYDUREON slows gastric emptying and can reduce the rate of absorption of orally administered drugs. Use with caution with oral medications.
  • Warfarin: Postmarketing reports with exenatide of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYDUREON.

Use in Specific Populations

  • Pregnant and Nursing Women: Based on animal data, BYDUREON may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure during pregnancy call 1-800-633-9081. When administered to a nursing woman, a decision should be made whether to discontinue nursing or to discontinue BYDUREON.
  • Pediatric Patients: Use in pediatric patients is not recommended as safety and effectiveness have not been established.

Please click here for Full Prescribing Information and click here for Medication Guide for BYDUREON 2 mg, including Boxed WARNING regarding risk of thyroid C-cell tumors.

Indication and Limitations of Use for ONGLYZA® (saxagliptin)


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

ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Important Safety Information for ONGLYZA

Contraindications

  • History of a serious hypersensitivity reaction to ONGLYZA (eg, anaphylaxis, angioedema, or exfoliative skin conditions)

Warnings and Precautions

  • Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking ONGLYZA, and in the SAVOR cardiovascular outcomes trial after initiating ONGLYZA. After initiating ONGLYZA, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue ONGLYZA and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while using ONGLYZA
  • Heart Failure: In SAVOR, a cardiovascular outcomes trial enrolling participants with established or multiple risk factors for atherosclerotic cardiovascular disease (ASCVD), more patients treated with ONGLYZA were hospitalized for heart failure compared to placebo. Patients with a prior history of heart failure or renal impairment had a higher risk for hospitalization for heart failure. Consider the risks and benefits of ONGLYZA in patients who have known risk factors for heart failure. Monitor for signs and symptoms. If heart failure develops, initiate appropriate management and consider discontinuation of ONGLYZA
  • Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin: When ONGLYZA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of confirmed hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia when used in combination with ONGLYZA
  • Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with ONGLYZA, including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with ONGLYZA, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue ONGLYZA, assess for other potential causes for the event, and institute alternative treatment for diabetes. Use caution in patients with a history of angioedema to another DPP-4 inhibitor as it is unknown whether they will be predisposed to angioedema with ONGLYZA
  • Severe and Disabling Arthralgia: There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue drug if appropriate
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug

Most Common Adverse Reactions

  • Most common adverse reactions reported in ≥5% of patients treated with ONGLYZA and more commonly than in patients treated with control were upper respiratory tract infection (7.7%, 7.6%), urinary tract infection (6.8%, 6.1%), and headache (6.5%, 5.9%)
  • When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo was 3.1%, 8.1% and 4.3%, respectively
  • Confirmed hypoglycemia was reported more commonly in patients treated with ONGLYZA 2.5 mg and ONGLYZA 5 mg compared to placebo in the add-on to glyburide trial (2.4%, 0.8% and 0.7%, respectively), with ONGLYZA 5 mg compared to placebo in the add-on to insulin (with or without metformin) trial (5.3% and 3.3%, respectively), with ONGLYZA 2.5 mg compared to placebo in the renal impairment trial (4.7% and 3.5%, respectively), and with ONGLYZA 5 mg compared to placebo in the add-on to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively)

Drug Interactions

  • Because ketoconazole, a strong CYP3A4/5 inhibitor, increased saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg when coadministered with a strong CYP3A4/5 inhibitor (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin)

Use in Specific Populations

  • Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min). ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter
  • Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. ONGLYZA, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when ONGLYZA is administered to a nursing woman
  • Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric patients have not been established

Please see US Full Prescribing Information and Medication Guide for ONGLYZA.

Indication and Important Limitations of Use for BYETTA® (exenatide) injection

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

  • Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.
  • Concurrent use with prandial insulin has not been studied and cannot be recommended.
  • BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA; consider other antidiabetic therapies for these patients.

Important Safety Information for BYETTA

Contraindications

  • BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

  • Never Share a BYETTA Pen Between Patients: Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed.
  • Pancreatitis: Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation and dose increases of BYETTA, observe patients carefully for pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYETTA should be discontinued promptly and should not be restarted if pancreatitis is confirmed.
  • Hypoglycemia: Increased risk of hypoglycemia when used in combination with a sulfonylurea (SU) or when used with a glucose-independent insulin secretagogues (eg, meglitinides). Clinicians may consider reducing the SU dose in patients receiving BYETTA to reduce the risk of hypoglycemia. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia.
  • Renal Impairment: Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure. Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
  • Gastrointestinal Disease: Because exenatide is commonly associated with gastrointestinal adverse reactions, BYETTA is not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
  • Immunogenicity: Patients may develop antibodies to exenatide. In 3 registration trials, antibody levels were measured in 90% of patients, with up to 4% of patients having high-titer antibodies and attenuated glycemic response. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
  • Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYETTA and other suspect medications and promptly seek medical advice.
  • Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

Most Common Adverse Reactions (≥5%)

  • 24-week monotherapy trial vs placebo (PBO): nausea (8% vs 0%).
  • Three 30-week combination trials of BYETTA added to metformin (MET) and/or SU vs PBO: nausea (44% vs 18%), vomiting (13% vs 4%), and diarrhea (13% vs 6%), feeling jittery (9% vs 4%), dizziness (9% vs 6%), headache (9% vs 6%), dyspepsia (6% vs 3%).
  • 16-week trial of BYETTA added to thiazolidinedione (TZD) ± MET vs PBO: nausea (40% vs 15%), vomiting (13% vs 1%), dyspepsia (7% vs 1%), diarrhea (6% vs 3%).
  • 30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs PBO: nausea (41% vs 8%), vomiting (18% vs 4%), diarrhea (18% vs 8%), headache (14% vs 4%), constipation (10% vs 2%), dyspepsia (7% vs 2%), asthenia (5% vs 1%).
  • Hypoglycemia: BYETTA as monotherapy vs PBO, 3.8% (10 mcg) and 5.2% (5 mcg) vs 1.3%; BYETTA vs PBO, with metformin (MET): 5.3% (10 mcg) and 4.5%(5 mcg) vs 5.3%; with SU, 35.7% (10 mcg) and 14.4% (5 mcg) vs 3.3%; with MET + SU, 27.8% (10 mcg) and 19.2% (5 mcg) vs 12.6%; with TZD, 10.7% (10 mcg) vs 7.1%; with insulin glargine, 24.8% (10 mcg) vs 29.5%.
  • Withdrawals: monotherapy trial: 2 of 155 BYETTA patients withdrew due to headache and nausea vs 0 PBO-treated patients. Three 30-week combination trials of BYETTA added to MET and/or SU vs PBO: nausea (3% vs <1%), vomiting (1% vs 0). 16-week trial of BYETTA added to TZD ± MET vs PBO: nausea (9%) and vomiting (5%), with <1% PBO patients withdrawing due to nausea. 30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs PBO: nausea (5.1% vs 0), vomiting (2.9% vs 0).

Drug Interactions

  • Oral Medications: BYETTA slows gastric emptying and can reduce the extent and rate of absorption of orally administered drugs. Use with caution with medications that have a narrow therapeutic index or require rapid gastrointestinal absorption. Oral medications dependent on threshold concentrations for efficacy, such as contraceptives or antibiotics, should be taken at least 1 hour before BYETTA.
  • Warfarin: Postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYETTA.

Use in Specific Populations

  • Pregnant and Nursing Women: Based on animal data, BYETTA may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure during pregnancy call 1-800-633-9081. When administered to a nursing woman, a decision should be made whether to discontinue nursing or discontinue BYETTA.
  • Pediatric Patients: Use in pediatric patients is not recommended as safety and effectiveness have not been established.

Please click here for US Full Prescribing Information and Medication Guide for BYETTA.

NOTES TO EDITORS

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the US15 and 415 million people worldwide.16 Type 2 diabetes accounts for approximately 90-95 percent of adults diagnosed with diabetes in the US.15 The prevalence of diabetes is projected to reach more than 642 million people worldwide by 2040.16 Type 2 diabetes is a chronic and progressive disease characterized by multiple pathophysiologic defects leading to elevated glucose levels.16,17 Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.18 It is estimated that nearly half of people living with type 2 diabetes are not achieving recommended A1C goals based on guidelines established by professional societies and advocacy organizations for diabetes management.18,19

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. Our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualized treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.

As a strategic therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas  – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centers, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com.

CONTACTS

Michele Meixell                                                 +1 302 885 2677
Abigail Bozarth                                                 +1 302 885 2677

References
1.    Heerspink HJL, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1095-P.
2.    Kosiborod M, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1094-P.
3.    Mentz R, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1039-P
4.    Henry R, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1185-P
5.    Ruggles J, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1014-P
6.    Wysham C, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1041-P
7.    Desai U, et al. American Diabetes Association Scientific Sessions 2016. Abstract #1218-P
8.    Konkar A, et al. American Diabetes Association Scientific Sessions 2016. Abstract #Late-Breaker LB-35
9.    Trevaskis J, et al. American Diabetes Association Scientific Sessions 2016. Abstract Oral #71-OR
10.    Ambery P, et al. American Diabetes Association Scientific Sessions 2016. Abstract #Late-Breaker LB-107
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