Janssen to Present Latest Data for Type 2 Diabetes Treatment INVOKANA® (canagliflozin) at American Diabetes Association 74th Scientific Sessions®

RARITAN, N.J., June 10, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that 15 presentations on INVOKANA^® (canagliflozin) will be made at the American Diabetes Association (ADA) 74^th Scientific Sessions^®, June 13-17 in San Francisco. The presentations include long-term safety and efficacy data for INVOKANA^®, findings of its effects on different patient populations, and evaluations of weight reduction and other health indicators in overweight and obese patients compared to sitagliptin.

Also presented will be cost-effectiveness simulation analyses and the first real-world data characterizing patients treated with INVOKANA^® in routine clinical practice.

INVOKANA^® is the first sodium glucose co‐transporter 2 (SGLT2) inhibitor available in the United States. It is an oral medication that reduces the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes.

"Healthcare providers who treat type 2 diabetes have widely adopted INVOKANA^® and we look forward to sharing with them the latest clinical and healthcare economics data about this therapy at the American Diabetes Association Scientific Sessions," said Norman Rosenthal, MD, FACE, FACP, canagliflozin compound development team leader, Janssen. "The data reflect our commitment to researching and providing innovative treatments to help improve health outcomes for patients living with type 2 diabetes."    

The abstracts for INVOKANA^® data accepted for presentation at the American Diabetes Association 74^th Scientific Sessions^® are as follows:

Clinical Data

Oral Presentations: Monday, June 16, 2014, 8:00 - 10:00 a.m. PT, SGLT2 Inhibitors Session

• Temporal Changes in Urinary Glucose Excretion, Urine Volume, and Plasma Volume in Subjects with Type 2 Diabetes Mellitus Treated with Canagliflozin (Presentation 263-OR)
• Long-term Efficacy and Safety of Canagliflozin in Older Patients with Type 2 Diabetes Mellitus Over 104 Weeks (Presentation 268-OR)

Poster Presentation: Saturday, June 14, 2014 11:30 a.m. - 1:30 p.m. PT, General Poster Session

• The Relationship between Weight and Weight Satisfaction in Two Phase 3 Trials of Canagliflozin vs. Sitagliptin (Poster No. 798-P)

Poster Presentations: Sunday, June 15, 2014 12:00 - 2:00 p.m. PT, General Poster Session

• Effect of Canagliflozin in Patients with Type 2 Diabetes Mellitus Based on Age and Estimated Glomerular Filtration Rate (Poster No. 1034-P)
• Quality Measure Attainment in Overweight/Obese Patients with Type 2 Diabetes Treated with Canagliflozin or Sitagliptin (Poster No. 1047-P)
• Effect of Canagliflozin in Patients with Type 2 Diabetes Mellitus Who Were, or Were Not, on Antihyperglycemic Agents at Screening (Poster No. 1078-P)
• Canagliflozin Reduces Serum Uric Acid in Patients with Type 2 Diabetes Mellitus (Poster No. 1090-P)
• Effect of Canagliflozin on Liver Function Tests in Patients with Type 2 Diabetes Mellitus (Poster No. 1092-P)
• Achievement of Diabetes-related Treatment Goals with Canagliflozin in Patients with Type 2 Diabetes Mellitus (Poster No. 1093-P)
• Consistent Effects of Canagliflozin Across Racial Subgroups of Patients with Type 2 Diabetes Mellitus (Poster No. 1095-P)
• Glycemic Efficacy of Canagliflozin Is Largely Independent of Baseline Beta-Cell Function or Insulin Sensitivity (Poster No. 1096-P)

Preclinical Data

Poster Presentation: Monday, June 16, 2014 12:00 - 2:00 p.m. PT, General Poster Session

• Canagliflozin and C-Peptide Clearance in SD Rats (Poster No. 1765-P)

Health Care Delivery and Economics

Poster Presentations: Sunday, June 15, 2014 12:00 - 2:00 p.m. PT, General Poster Session

• Characteristics of Patients with Type 2 Diabetes Mellitus Initiating Therapy with Canagliflozin (Poster No. 1181-P)
• The Cost-Effectiveness of Canagliflozin vs. Sitagliptin as an Add-on to Metformin in the Treatment of Type 2 Diabetes Mellitus in the U.S. (Poster No. 1190-P)
• Cost-Effectiveness Analysis of Canagliflozin vs. Maximally Titrated Glimepiride as an Add-on to Metformin in Patients with Type 2 Diabetes Mellitus in the United States (Poster No. 1189-P)

Janssen will also present two abstracts related to epidemiology and healthcare delivery that do not include INVOKANA^® data:

Epidemiology

Poster Presentation: Sunday, June 15, 2014 12:00 - 2:00 p.m. PT, General Poster Session

• Predictive Modeling of Potentially Preventable Hospital Admissions for Diabetes in Electronic Health Care Databases (Poster No. 1424-P)

Health Care Delivery

Poster Presentation: Sunday, June 15, 2014 12:00 - 2:00 p.m. PT, General Poster Session

• Transitions of Care for People with Type 2 Diabetes Mellitus: Utilization of Antihyperglycemic Agents Pre- and Post-Hospitalization (Poster No. 1160-P)

Abstracts of all accepted presentations can be accessed on the American Diabetes Association Scientific Sessions website.

About INVOKANA^®

INVOKANA^® is an oral medication that selectively inhibits SGLT2, a cell transporter responsible for the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes.

In March 2013, the United States Food and Drug Administration (FDA) approved INVOKANA^® as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA^® has since been widely adopted and today it is the number-one branded therapy prescribed by U.S. endocrinologists when adding or switching non-insulin type 2 diabetes medications. INVOKANA^® also is approved in the European Union, Australia, Canada, Chile, Mexico and Switzerland.

INVOKANA^® has been studied as monotherapy and in combination with other type 2 diabetes therapies. The comprehensive global Phase 3 clinical development program for INVOKANA^® enrolled 10,285 patients in nine studies and was one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. In two separate trials, INVOKANA^® 300mg demonstrated greater reductions in A1C versus sitagliptin 100mg at 52 weeks, as well as greater reductions in body weight and systolic blood pressure. The recommended starting dose on INVOKANA^® is 100mg. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.

The most common adverse events with INVOKANA^® are genital mycotic (fungal) infections, urinary tract infections and increased urination. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies.

About Type 2 Diabetes

An estimated 371 million worldwide are living with diabetes¹ and approximately 25.8 million people have diabetes in the United States.² Type 2 diabetes comprises 90 percent of people with diabetes,³ which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin.

Nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, and if left uncontrolled, type 2 diabetes can lead to serious complications.^4,5,6 Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.⁷

INDICATION STATEMENT
WHAT IS INVOKANA®?

• INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
• INVOKANA® is not for people with type 1 diabetes.
• INVOKANA® is not for people with diabetic ketoacidosis (increased ketones in blood or urine).
• It is not known if INVOKANA® is safe and effective in children under 18 years of age.
  

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT INVOKANA^®?
INVOKANA^® can cause important side effects, including:

• Dehydration. INVOKANA^® can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension).

You may be at higher risk of dehydration if you:

• have low blood pressure
• take medicines to lower your blood pressure, including diuretics (water pill)
• are on low sodium (salt) diet
• have kidney problems
• are 65 years of age or older

• Vaginal yeast infection. Women who take INVOKANA^® may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA^® may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

WHO SHOULD NOT TAKE INVOKANA^®?
Do not take INVOKANA^® if you:

• are allergic to canagliflozin or any of the ingredients in INVOKANA^®. See the end of the Medication Guide for a list of ingredients in INVOKANA^®. Symptoms of allergic reaction to INVOKANA^® may include:
  • rash
  • raised red patches on your skin (hives)
  • swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
    have severe kidney problems or are on dialysis

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING INVOKANA^®?
Before you take INVOKANA^®, tell your doctor if you:

• have kidney problems
• have liver problems
• are on a low sodium (salt) diet. Your doctor may change your diet or your dose of INVOKANA^®.
• have ever had an allergic reaction to INVOKANA^®
• have other medical conditions
• are pregnant or plan to become pregnant. It is not known if INVOKANA^® will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if INVOKANA^® passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking INVOKANA^®.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

INVOKANA^® may affect the way other medicines work, and other medicines may affect how INVOKANA^® works. Especially tell your doctor if you take:

• diuretics (water pills)
• rifampin (used to treat or prevent tuberculosis)
• phenytoin or phenobarbital (used to control seizures)
• ritonavir (Norvir®, Kaletra®, Lopinavir®)* (used to treat HIV infection)
• digoxin (Lanoxin®)* (used to treat heart problems)

Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE INVOKANA^®?

• Take INVOKANA^® by mouth 1 time each day exactly as your doctor tells you to take it.
• Your doctor will tell you how much INVOKANA^® to take and when to take it. Your doctor may change your dose if needed.
• It is best to take INVOKANA^® before the first meal of the day.
• Your doctor may tell you to take INVOKANA^® along with other diabetes medicines. Low blood sugar can happen more often when INVOKANA^® is taken with certain other diabetes medicines. See "What are the possible side effects of INVOKANA^®?"
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of INVOKANA^® at the same time. Talk to your doctor if you have questions about a missed dose.
• If you take too much INVOKANA^®, call your doctor or go to the nearest hospital emergency room right away. When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• Stay on your prescribed diet and exercise program while taking INVOKANA^®.
• Check your blood sugar as your doctor tells you to.
• INVOKANA^® will cause your urine to test positive for glucose.
• Your doctor may do certain blood tests before you start INVOKANA^® and during treatment as needed. Your doctor may change your dose of INVOKANA^® based on the results of your blood tests.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF INVOKANA^®?
INVOKANA^® may cause serious side effects, including:
See "What is the most important information I should know about INVOKANA^®?"

• kidney problems
• a high amount of potassium in your blood (hyperkalemia)
• low blood sugar (hypoglycemia). If you take INVOKANA^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA^®.

Signs and symptoms of low blood sugar may include:

• headache
• drowsiness
• weakness
• dizziness
• confusion
• irritability
• hunger
• fast heartbeat
• sweating
• shaking or feeling jittery
• serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA^® and call your doctor right away or go to the nearest hospital emergency room. See "Who should not take INVOKANA^®?". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of INVOKANA^® include:

• vaginal yeast infections and yeast infections of the penis (See "What is the most important information I should know about INVOKANA^®?")
• urinary tract infection
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of INVOKANA^®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.

Please see the full Prescribing Information and Medication Guide.

Trademarks are those of their respective owners.

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Scientific Affairs, LLC are part of the Janssen Pharmaceutical Companies. Please visit http://www.janssenrnd.com for more information.

References

¹ International Diabetes Federation, Diabetes Atlas 5th Edition 2012 Update, New estimates for 2012 of diabetes prevalence, mortality, and healthcare expenditures. Available at: http://www.idf.org/sites/default/files/IDF%20Diabetes%20Atlas%205th%20Edition%202012%20Update_1.ppt.  Accessed  April 4, 2013.

² Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.

³ Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: Diagnosis and classification of diabetes mellitus. Geneva, World Health Organization, 1999 (WHO/NCD/NCS/99.2).

⁴ Bailey CJ. Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci. 2011;32(2):63-71.

⁵ Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013 Feb 15. Epub ahead of print.

⁶ World Health Organization, Media Centre, Diabetes, Fact sheet Number 312. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed April 1, 2013.

⁷ Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.

SOURCE Janssen Research & Development, LLC

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