AstraZeneca to Highlight Scientific Advancements Across Its Diabetes Portfolio at the American Diabetes Association … – Business Wire (press release)

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and its global biologics research and development arm, MedImmune, today announced that a lot more compared to 60 abstracts reporting results of the company’s research and development in diabetes have actually been accepted at the 76^th Scientific Sessions of the American Diabetes Association (ADA) in Brand-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 certainly likewise 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 manage 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 manage 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 manage along with a solid focus on delaying cardiovascular and chronic kidney disease complications.”

The studies to be presented evaluate the management of multiple risk factors associated along 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 solid global collaborations along with health experts, patient advocates and policymakers have actually established it as a leader in transforming the management and treatment of diabetes. At ADA, the company will certainly present a wealth of scientific knowledge generated along 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 along 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 along 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 manage in Patients along 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 along with Type 2 Diabetes (Poster 1014-P, Sunday June 12, 12:00 pm CDT)⁵
• DURATION-1 Extension in Patients along 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 along with Subsequent Glycemic manage Among Patients along 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

• MEDI416six 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 and balanced 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, 1:4five pm CDT)¹¹

Real-globe evidence to advice drive insights in to treatment patterns globally

• Advances in Diabetes Care 199six to 2012: A Terrific Investment (Oral 350-OR, Monday June 13, 4:30 pm CDT)¹²
• Real-globe 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 manage in Patients along with Type 2 Diabetes: Retrospective Data from 22,272 People (Poster 1558-P, Sunday June 12, 12:00 pm CDT)¹⁴

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

Indication and Limitations of Use for FARXIGA^®(dapagliflozin)

FARXIGA is indicated as an adjunct to diet plan and workout to improve glycemic manage in adults along with type 2 diabetes mellitus.

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

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

Important Safety Guide 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 triggers intravascular volume contraction. Symptomatic hypotension can easily occur after initiating FARXIGA, particularly in patients along with impaired renal function (eGFR <60 mL/min/1.73 m²), elderly patients, or patients on loop diuretics. Prior to initiating FARXIGA in patients along with one or a lot more of these characteristics, assess and appropriate volume status. After initiating therapy, monitor for signs and symptoms of hypotension.
• Ketoacidosis has actually been reported in patients along with type 1 and type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA. Assess patients that present along with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue FARXIGA, evaluate and treat promptly. Prior to initiating FARXIGA, think of risk factors for ketoacidosis. Patients on FARXIGA might require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• Impairment in Renal Function: FARXIGA improves serum creatinine and decreases eGFR. Elderly patients and patients along with impaired renal function could be a lot more susceptible to these changes. Side reactions related to renal function can easily occur after initiating FARXIGA. Prior to initiating FARXIGA, evaluate renal function and monitor periodically thereafter. Discontinue FARXIGA as soon as eGFR is persistently <60 mL/min/1.73 m².
• Urosepsis and Pyelonephritis: Serious urinary tract infections have actually been reported along 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 along with Concomitant Use along with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. FARXIGA can easily increase the risk of hypoglycemia as soon as combined along with these agents. think of a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia as soon as used in combination along with FARXIGA.
• Genital Mycotic Infections: FARXIGA improves the risk of genital mycotic infections. Patients along with a history of genital mycotic infections were a lot more most likely to produce genital mycotic infections. Monitor and treat appropriately.
• Increases in Low-Density Lipoprotein cholesterol levels (LDL-C) occur along 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 along with FARXIGA and no cases along 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 actually an effect on pre-existing bladder tumors. FARXIGA ought to not be used in patients along with energetic bladder cancer. Use along with caution in patients along with a prior history of bladder cancer.

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

Adverse Reactions

• In a pool of 12 placebo-controlled studies, the most common Side reactions (≥5%) associated along with FARXIGA five 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 Personal Populations

• Pregnant Women: There are no adequate and well-controlled studies of FARXIGA in pregnant women. think of correct alternative therapies, especially throughout the second and third trimesters.
• Nursing Mothers: It is not known whether FARXIGA is excreted in human milk. Due to the potential for serious Side reactions in nursing infants from FARXIGA, discontinue nursing or discontinue FARXIGA.
• Geriatric Use: A better proportion of patients ≥6five years treated along with FARXIGA had Side reactions related to volume depletion and renal impairment or failure compared to patients treated along with placebo. No FARXIGA dose modification is recommended based on age.

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

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

BYDUREON is indicated as an adjunct to diet plan and workout to improve glycemic manage in adults along with type 2 diabetes mellitus.

• BYDUREON is not recommended as first-line therapy for patients that have actually inadequate glycemic manage on diet plan and workout Due to 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, ought to not be used in patients along with type 1 diabetes or diabetic ketoacidosis, and cannot be recommended for use along with insulin.
• BYDUREON and BYETTA^® (exenatide) injection both contain the same energetic ingredient, exenatide, and ought to not be used together.
• Exenatide has actually been associated along with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients along with a history of pancreatitis are at increased risk for pancreatitis while using BYDUREON; think of others antidiabetic therapies for these patients.
• BYDUREON is not indicated for weight loss.

Important Safety Guide for BYDUREON

WARNING: RISK OF THYROID C-CELL TUMORS

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

Contraindications

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

Warnings and Precautions

• Pancreatitis: Based on postmarketing data, exenatide has actually been associated along 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, along with or devoid of vomiting). If pancreatitis is suspected, BYDUREON ought to be discontinued promptly and ought to not be restarted if pancreatitis is confirmed.
• Increased Risk of Hypoglycemia along with Concomitant Use of Insulin Secretagogues or Insulin: think of reducing the insulin secretagogues (e.g., sulfonylureas) or insulin dose to reduce the risk of hypoglycemia.
• Renal Impairment: ought to not be used in patients along with severe renal impairment or end-stage renal disease. Use along with caution in patients along with renal transplantation or moderate renal failure. Postmarketing reports of altered renal function along 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 typically associated along with gastrointestinal Side reactions, BYDUREON is not recommended in patients along with severe gastrointestinal disease (eg, gastroparesis).
• Immunogenicity: Patients might produce antibodies to exenatide. In five registration trials, attenuated glycemic response was associated in 6% of BYDUREON-treated patients along with antibody formation. If worsening of or failure to achieve adequate glycemic manage occurs, think of alternative antidiabetic therapy.
• Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients ought to discontinue BYDUREON and others suspect medications and promptly seek medical advice.
• Injection-Site Reactions: Postmarketing reports of serious injection-site reactions (eg, abscess, cellulitis, and necrosis), along with or devoid of subcutaneous nodules, along with the use of BYDUREON.
• Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction along with BYDUREON or any others antidiabetic drug.

Adverse Reactions

• The most common (≥5%) Side reactions reported in BYDUREON-treated patients and occurring a lot more regularly compared to 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 easily reduce the rate of absorption of orally administered drugs. Use along with caution along with oral medications.
• Warfarin: Postmarketing reports along with exenatide of increased global normalized ratio (INR) sometimes associated along with bleeding along with concomitant use of warfarin. Monitor INR regularly until constant upon initiation or alteration of BYDUREON.

Use in Personal Populations

• Pregnant and Nursing Women: Based on animal data, BYDUREON might cause fetal harm and ought to be used throughout pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure throughout pregnancy call 1-800-633-9081. as soon as administered to a nursing woman, a decision ought to be made whether to discontinue nursing or to discontinue BYDUREON.

• Pediatric Patients: Use in pediatric patients is not recommended as safety and effectiveness have actually not been established.

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

Indication and Limitations of Use for ONGLYZA^®(saxagliptin)

ONGLYZA is indicated as an adjunct to diet plan and workout to improve glycemic manage in adults along with type 2 diabetes mellitus.

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

Important Safety Guide for ONGLYZA

Contraindications

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

Warnings and Precautions

• Pancreatitis: There have actually 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 correct management. It is unknown whether patients along with a history of pancreatitis are at increased risk of creating pancreatitis while using ONGLYZA
• Heart Failure: In SAVOR, a cardiovascular outcomes trial enrolling participants along with established or multiple risk factors for atherosclerotic cardiovascular disease (ASCVD), a lot more patients treated along with ONGLYZA were hospitalized for heart failure compared to placebo. Patients along with a prior history of heart failure or renal impairment had a better risk for hospitalization for heart failure. think of the risks and benefits of ONGLYZA in patients that have actually known risk factors for heart failure. Monitor for signs and symptoms. If heart failure develops, initiate correct management and think of discontinuation of ONGLYZA
• Hypoglycemia along with Concomitant Use of Sulfonylurea or Insulin: as soon as ONGLYZA was used in combination along with a sulfonylurea or along with insulin, medications known to cause hypoglycemia, the incidence of confirmed hypoglycemia was increased over that of placebo used in combination along with a sulfonylurea or along with insulin. Therefore, a lower dose of the insulin secretagogue or insulin could be needed to minimize the risk of hypoglycemia as soon as used in combination along with ONGLYZA
• Hypersensitivity Reactions: There have actually been postmarketing reports of serious hypersensitivity reactions in patients treated along with ONGLYZA, including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the initial 3 months after initiation of treatment along with ONGLYZA, along with some reports occurring after the initial dose. If a serious hypersensitivity reaction is suspected, discontinue ONGLYZA, assess for others potential triggers for the event, and institute alternative treatment for diabetes. Use caution in patients along with a history of angioedema to one more DPP-4 inhibitor as it is unknown whether they will certainly be predisposed to angioedema along with ONGLYZA
• Severe and Disabling Arthralgia: There have actually 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 went through relief of symptoms upon discontinuation of the medication. A subset of patients went through a recurrence of symptoms as soon as restarting the same drug or a different DPP-4 inhibitor. think of DPP-4 inhibitors as a feasible cause for severe joint pain and discontinue drug if appropriate
• Macrovascular Outcomes: There have actually been no clinical studies establishing conclusive evidence of macrovascular risk reduction along with ONGLYZA or any others antidiabetic drug

Most Common Side Reactions

• Most common Side reactions reported in ≥5% of patients treated along with ONGLYZA and a lot more typically compared to in patients treated along with manage 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 along with a thiazolidinedione, the incidence of peripheral edema for ONGLYZA 2.five mg, five mg, and placebo was 3.1%, 8.1% and 4.3%, respectively
• Confirmed hypoglycemia was reported a lot more typically in patients treated along with ONGLYZA 2.five mg and ONGLYZA five mg compared to placebo in the add-on to glyburide trial (2.4%, 0.8% and 0.7%, respectively), along with ONGLYZA five mg compared to placebo in the add-on to insulin (along with or devoid of metformin) trial (5.3% and 3.3%, respectively), along with ONGLYZA 2.five mg compared to placebo in the renal impairment trial (4.7% and 3.5%, respectively), and along with ONGLYZA five mg compared to placebo in the add-on to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively)

Drug Interactions

• Because ketoconazole, a solid CYP3A4/five inhibitor, increased saxagliptin exposure, the dose of ONGLYZA ought to be limited to 2.five mg as soon as coadministered along with a solid CYP3A4/five inhibitor (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin)

Use in Personal Populations

• Patients along with Renal Impairment: The dose of ONGLYZA is 2.five mg once everyday for patients along with moderate or severe renal impairment, or along with end-stage renal disease requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min). ONGLYZA ought to be administered following hemodialysis. ONGLYZA has actually 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 others antidiabetic medications, ought to be used throughout pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because several drugs are secreted in human milk, caution ought to be exercised as soon as ONGLYZA is administered to a nursing woman
• Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric patients have actually not been established

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

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

BYETTA is indicated as an adjunct to diet plan and workout to improve glycemic manage in adults along with type 2 diabetes mellitus.

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

Important Safety Guide for BYETTA

Contraindications

• BYETTA is contraindicated in patients along 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 actually been associated along with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation and dose improves of BYETTA, observe patients carefully for pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, along with or devoid of vomiting). If pancreatitis is suspected, BYETTA ought to be discontinued promptly and ought to not be restarted if pancreatitis is confirmed.
• Hypoglycemia: Increased risk of hypoglycemia as soon as used in combination along with a sulfonylurea (SU) or as soon as used along with a glucose-independent insulin secretagogues (eg, meglitinides). Clinicians might think of reducing the SU dose in patients receiving BYETTA to reduce the risk of hypoglycemia. as soon as used along with insulin, evaluate and think of reducing the insulin dose in patients at increased risk of hypoglycemia.
• Renal Impairment: ought to not be used in patients along with severe renal impairment or end-stage renal disease. Use along with caution in patients along with renal transplantation or as soon as initiating or escalating the dose in patients along 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 typically associated along with gastrointestinal Side reactions, BYETTA is not recommended in patients along with severe gastrointestinal disease (eg, gastroparesis).
• Immunogenicity: Patients might produce antibodies to exenatide. In 3 registration trials, antibody levels were measured in 90% of patients, along with up to 4% of patients having high-titer antibodies and attenuated glycemic response. If worsening of or failure to achieve adequate glycemic manage occurs, think of alternative antidiabetic therapy.
• Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients ought to discontinue BYETTA and others suspect medications and promptly seek medical advice.
• Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction along with BYETTA or any others antidiabetic drug.

Most Common Side 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% (five mcg) vs 1.3%; BYETTA vs PBO, along with metformin (MET): 5.3% (10 mcg) and 4.5%

(five mcg) vs 5.3%; along with SU, 35.7% (10 mcg) and 14.4% (five mcg) vs 3.3%; along with MET + SU, 27.8% (10 mcg) and 19.2% (five mcg) vs 12.6%; along with TZD, 10.7% (10 mcg) vs 7.1%; along with insulin glargine, 24.8% (10 mcg) vs 29.5%.

• Withdrawals: monotherapy trial: 2 of 15five BYETTA patients withdrew because of 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%), along with <1% PBO patients withdrawing because of 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 easily reduce the extent and rate of absorption of orally administered drugs. Use along with caution along with medications that have actually a narrow therapeutic index or require rapid gastrointestinal absorption. Oral medications dependent on threshold concentrations for efficacy, such as contraceptives or antibiotics, ought to be taken at least 1 hour Prior to BYETTA.
• Warfarin: Postmarketing reports of increased global normalized ratio (INR) sometimes associated along with bleeding along with concomitant use of warfarin. Monitor INR regularly until constant upon initiation or alteration of BYETTA.

Use in Personal Populations

• Pregnant and Nursing Women: Based on animal data, BYETTA might cause fetal harm and ought to be used throughout pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure throughout pregnancy call

1-800-633-9081. as soon as administered to a nursing woman, a decision ought to be made whether to discontinue nursing or discontinue BYETTA.

• Pediatric Patients: Use in pediatric patients is not recommended as safety and effectiveness have actually not been established.

Please click here for US Full Prescribing Guide 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 41five million people worldwide.¹⁶ Type 2 diabetes accounts for approximately 90-9five percent of adults diagnosed along with diabetes in the US.¹⁵ The prevalence of diabetes is projected to reach a lot more compared to 642 million people international by 2040.¹⁶ Type 2 diabetes is a chronic and progressive disease characterized by multiple pathophysiologic defects leading to elevated glucose levels.^16,17 Considerable unmet requires still exist, as several patients stay inadequately controlled on their current glucose-lowering regimen.¹⁸ It is estimated that nearly half of people living along 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 along with the goal of creating 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 along with Considerable 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 advice a lot more patients achieve treatment triumph earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

About AstraZeneca

AstraZeneca is a global, innovation-steered 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 a lot more Guide please visit http://ift.tt/1sRp7EO.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-steered 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 vital 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, along with additional sites in Cambridge, UK and Mountain View, CA. For a lot more information, please visit www.medimmune.com.

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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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