How Long Does Invokana Stay In Your System

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New Long-Term Data Show INVOKANA® (canagliflozin) Lowers Blood Glucose in Older Patients with Type 2 Diabetes Inadequately Controlled on Other Therapies

New Long-Term Data Show INVOKANA® (canagliflozin) Lowers Blood Glucose in Older Patients with Type two Diabetes Inadequately Controlled on Other Therapies

Phase 3 Written report Results Also Demonstrate INVOKANA® Reduces Secondary Endpoints of Trunk Weight and Systolic Blood Pressure

Note: This release corresponds to American Diabetes Association (ADA) abstract 268-OR

RARITAN, North.J., JUNE sixteen, 2014 – Janssen Enquiry & Development, LLC (Janssen) today announced new results from a 104-week Stage 3 clinical report evaluating the long-term effects of INVOKANA^® (canagliflozin) in patients anile 55 to lxxx years with type two diabetes inadequately controlled on current antihyperglycemic therapies. The randomized double-blind report showed INVOKANA^® 100 milligrams (mg) and 300 mg, compared to placebo, provided greater reductions in blood glucose (A1C), and greater reductions in secondary endpoints of fasting plasma glucose, body weight and systolic blood pressure.

Older adults accept the highest prevalence of diabetes of any historic period grouping, with more than than 25 percent of U.S. adults aged 65 years and older living with diabetes.[1] The aging of the overall U.Southward. population is best-selling as a driver of the diabetes epidemic.[two] Type 2 diabetes comprises 90 to 95 pct of people with diabetes and if left uncontrolled can lead to serious complications.[ane]

"The results presented today reinforce the positive effects of INVOKANA^® on key health measures for older people with blazon 2 diabetes," said Norman Rosenthal, MD, Confront, FACP, canagliflozin compound evolution team leader, Janssen. "As INVOKANA^® continues its rapid uptake in the type 2 diabetes community, nosotros remain committed to enhancing understanding of its full impact on different patient types and the healthcare system overall."

In the long-term study (DIA3010), after 104 weeks, levels of A1C, the principal endpoint, were significantly reduced with INVOKANA^® 100 mg and 300 mg, respectively, relative to placebo: -0.49 percentage (95 pct conviction interval [CI] -0.65, -0.32) and -0.60 percentage (CI -0.77, -0.44). A1C, also called hemoglobin A1c, is the percent of red blood cell hemoglobin with glucose attached to it, and is an indicator of average blood glucose over the previous 2 to three months.[3]

INVOKANA^® 100 mg and 300 mg, respectively, besides resulted in significant improvements in a number of secondary endpoints relative to placebo:

The percent of patients reaching the A1C goal level of less than 7.0 percent: 15.six percent (CI 7.2, 24.0) and 21.7 percent (CI 13.0, 30.3)
Body weight reduction: -2.3 percent (CI -3.one, -i.six) and -3.2 percentage (CI -iv.0, -two.four)
Fasting plasma glucose reduction: -21.four mg/dL (CI -28.v, -14.2) and -23.4 mg/dL (CI -30.vi, -16.two)
Systolic blood pressure reduction: -5.8 mm Hg (CI -viii.0, -3.five and -seven.5 mm Hg (CI -9.eight, -5.2)
Increased levels of HDL-C (high-density lipoprotein cholesterol): three.six percent (CI 0.4, half dozen.9) and 4.8 percent (CI i.5, 8.i)

Treatment with INVOKANA^® was as well associated with non-significant changes, relative to placebo, in claret triglycerides and LDL-C (low-density lipoprotein cholesterol).

The overall incidence of adverse events (AEs) for INVOKANA^® 100 mg, 300 mg and placebo, respectively, was 88 percent, 90 percent, and 86 pct. AE-related discontinuation rates were v percent, 10 percent and 7 percent, and serious AE rates were similar across groups. Higher incidences of urinary tract infections, genital mycotic infections, osmotic diuresis (increased urination)-related AEs, and book depletion were seen with INVOKANA^® compared to placebo. Hypoglycemia was more than common with INVOKANA^® than placebo, with few severe episodes beyond groups. The AE profile was consequent with that seen among a broad range of INVOKANA^®-treated patients.

For more than details about the study, visit the American Diabetes Association Scientific Sessions website and search online abstracts for presentation number 268-OR.

The results presented today are among a full of 15 presentations on INVOKANA^® made at the American Diabetes Association 74^th Scientific Sessions^®in San Francisco.

About INVOKANA^®

INVOKANA^® is the beginning sodium glucose co‐transporter ii (SGLT2) inhibitor available in the United States.

It is an oral medication that reduces the reabsorption of glucose past the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with blazon 2 diabetes. In clinical trials, INVOKANA^® besides has been shown to provide secondary endpoint reductions in body weight and systolic blood force per unit area.

In March 2013, the Us Food and Drug Administration (FDA) approved INVOKANA^® as a single amanuensis as an adjunct to nutrition and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA^® has since been widely adopted and today information technology is the number-one branded therapy prescribed past U.S. endocrinologists when adding or switching not‐insulin blazon 2 diabetes medications. INVOKANA^® also is canonical in the European Marriage (31 countries), Australia, Canada, Chile, Mexico, Switzerland, Singapore, South Korea, Peru, Aruba, State of kuwait, United Arab Emirates and Guatemala.

INVOKANA^® has been studied as monotherapy and in combination with other type 2 diabetes therapies.

The comprehensive global Stage iii clinical development programme for INVOKANA^® enrolled 10,285 patients in nine studies and was one of the largest clinical programs in type two diabetes submitted to health authorities to date. In two separate trials, INVOKANA^® 300mg demonstrated greater reductions in A1C versus sitagliptin 100mg at 52 weeks, every bit well as greater reductions in body weight and systolic blood pressure. The recommended starting dose on INVOKANA^® is 100mg. A1C is the percent of carmine blood cell hemoglobin with glucose attached to it and an indicator of boilerplate claret glucose over the previous two to three months.

The most common agin 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 iii studies.

Near Blazon two Diabetes

An estimated 371 one thousand thousand worldwide are living with diabetes[four] and approximately 25.8 meg people accept diabetes in the United States.[v] Type 2 diabetes comprises xc pct of people with diabetes,[6] which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell role to keep up with the body's demand for insulin.

Almost half of adults with type 2 diabetes do not accomplish recommended levels of glucose control, and if left uncontrolled, type ii diabetes can lead to serious complications.[7],[viii],[9] Improved glycemic control has been demonstrated to reduce the onset and progression of these complications. [10]

INDICATION STATEMENT
WHAT IS INVOKANA ^® ?

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

Of import SAFETY Information

WHAT IS THE MOST Important Data I SHOULD KNOW Near INVOKANA ^® ?
INVOKANA^® can cause important side effects, including:

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

You may exist at higher risk of dehydration if you:
- accept low claret pressure
- take medicines to lower your claret pressure, including diuretics (water pill)
- are on low sodium (table salt) nutrition
- have kidney issues
- are 65 years of historic period or older

Vaginal yeast infection.Women who take INVOKANA^® may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
- vaginal odour
- white or yellowish vaginal discharge (discharge may exist lumpy or await like cottage cheese)
- vaginal itching
Yeast infection of the penis (balanitis or balanoposthitis).Men who have INVOKANA^® may get a yeast infection of the peel effectually the penis. Certain men who are not circumcised may accept swelling of the penis that makes information technology hard to pull dorsum the peel 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 advise y'all use an over-the-counter antifungal medicine. Talk to your doctor right abroad if you use an over-the-counter antifungal medication and your symptoms practice not become abroad.
WHO SHOULD Not Have INVOKANA ^® ?
Do non accept INVOKANA ^® if you:

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

WHAT SHOULD I TELL MY Doctor Before TAKING INVOKANA ^® ?
Before you take INVOKANA^®, tell your medico if yous:

have kidney issues
have liver problems
are on a low sodium (salt) diet. Your medico may change your diet or your dose of INVOKANA^®.
take ever had an allergic reaction to INVOKANA^®
accept other medical conditions
are pregnant or plan to become significant. It is non known if INVOKANA^® will harm your unborn babe. If you are pregnant, talk with your dr. nigh the best mode to command your blood sugar while you are significant.
are breastfeeding or plan to breastfeed. It is not known if INVOKANA^® passes into your breast milk. Talk with your doctor almost the best style to feed your infant if you are taking INVOKANA^®.

Tell your doctor almost all the medicines y'all take, including prescription and not-prescription medicines, vitamins, and herbal supplements.

INVOKANA^® may touch on the style other medicines piece of work, and other medicines may affect how INVOKANA^® works. Especially tell your doctor if you have:

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

Ask your doctor or chemist for a listing of these medicines if y'all are not sure if your medicine is listed above.
Know the medicines you take. Keep a list of them and show it to your medico and chemist when yous get a new medicine.

HOW SHOULD I Take INVOKANA ^® ?

Take INVOKANA^® by mouth one fourth dimension each day exactly equally your doctor tells you to take it.
Your doctor will tell y'all how much INVOKANA^® to take and when to take information technology. Your medico may change your dose if needed.
Information technology is best to take INVOKANA^® before the first meal of the solar day.
Your doctor may tell you to take INVOKANA^® forth with other diabetes medicines. Low blood sugar can happen more than 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 every bit you remember. If it is near time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Exercise non accept ii doses of INVOKANA^® at the same fourth dimension. Talk to your dr. if you have questions about a missed dose.
If y'all take too much INVOKANA^®, call your doctor or go to the nearest hospital emergency room correct away. When your body is under some types of stress, such as fever, trauma (such equally a car blow), infection, or surgery, the amount of diabetes medicine yous need may change. Tell your doctor right away if you have any of these weather and follow your doctor's instructions.
Stay on your prescribed diet and exercise program while taking INVOKANA^®.
Check your blood sugar equally your doctor tells yous to.
INVOKANA^® will cause your urine to test positive for glucose.
Your doctor may do certain blood tests before you start INVOKANA^® and during handling 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 furnishings, including:
Run into"What is the most important information I should know about INVOKANA ^® ?"

kidney problems
a high amount of potassium in your blood (hyperkalemia)
low blood carbohydrate (hypoglycemia). If yous accept 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 demand to be lowered while yous take INVOKANA^®.

Signs and symptoms of depression blood sugar may include:

headache
drowsiness
weakness
dizziness
defoliation
irritability
hunger
fast heartbeat
sweating
shaking or feeling jittery
serious allergic reaction. If you accept whatever symptoms of a serious allergic reaction, stop taking INVOKANA^® and call your dr. correct away or get to the nearest hospital emergency room. See"Who should not take INVOKANA ^® ?". Your doctor may requite you a medicine for your allergic reaction and prescribe a unlike 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 of import data I should know nigh INVOKANA ^® ?")
urinary tract infection
changes in urination, including urgent demand to urinate more often, in larger amounts, or at nighttime

Tell your doctor if you have any side upshot that bothers you or that does non get abroad. These are non all the possible side effects of INVOKANA^®. For more information, ask your doctor or chemist.

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

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

Please see the full Prescribing Data and Medication Guide .

Trademarks are those of their respective owners.

About Janssen Enquiry & Development, LLC
At Janssen, nosotros are defended to addressing and solving some of the almost of import 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 Diplomacy, LLC are part of the Janssen Pharmaceutical Companies. Please visit http://www.janssenrnd.com for more than information.

This printing release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of time to come events. If underlying assumptions testify inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inquiry & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are non express to: economical factors, such as interest charge per unit and currency substitution charge per unit fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health intendance products and services; changes to governmental laws and regulations and domestic and strange wellness care reforms; general industry conditions including trends toward health care toll containment; and increased scrutiny of the health care industry by government agencies. A further listing and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form x-1000 for the fiscal twelvemonth ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on asking from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update whatsoever frontwards-looking statements as a upshot of new data or future events or developments.

###

References

[1] Centers for Disease Command and Prevention. National diabetes fact sheet: national estimates and full general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.Southward. Department of Health and Homo Services, Centers for Disease Control and Prevention, 2011.

[two] American Diabetes Association .Older Adults. Bachelor at: www.diabetes.org/in-my-community/awareness-programs/older-adults/.

[3] American Diabetes Association. Living with diabetes: A1C. Available at: http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-command/a1c/?keymatch=A1c.

[4] International Diabetes Federation, Diabetes Atlas fifth Edition 2012 Update, New estimates for 2012 of diabetes prevalence, mortality, and healthcare expenditures. Bachelor at: http://www.idf.org/sites/default/files/IDF%20Diabetes%20Atlas%205th%20Edition%202012%20Update_1.ppt.

[5] Centers for Disease Control and Prevention. National diabetes fact sail: national estimates and general information on diabetes and prediabetes in the United states of america, 2011. Atlanta, GA: U.Southward. Department of Health and Human Services, Centers for Affliction Control and Prevention, 2011.

[6] Definition, diagnosis and nomenclature of diabetes mellitus and its complications. Part ane: Diagnosis and nomenclature of diabetes mellitus. Geneva, World Health Organization, 1999 (WHO/NCD/NCS/99.two).

[7] Bailey CJ. Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci. 2011;32(ii):63-71.

[eight] 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 Intendance. 2013 February 15. Epub ahead of print.

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

[ten] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the The states, 2011. Atlanta, GA: U.Southward. Department of Wellness and Human Services, Centers for Disease Command and Prevention, 2011.

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