RARITAN, N.J., June 13, 2016 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced results from a Phase 2, randomized study showing glycemic improvements in adults with type 1 diabetes mellitus (T1DM), when treated with canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, plus insulin. These data were accepted for oral presentation at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA) taking place June 10-14, 2016 in New Orleans, La. Currently indicated for the treatment of adults with type 2 diabetes mellitus (T2DM), canagliflozin is not indicated for the treatment of type 1 diabetes.
This 18-week, randomized Phase 2 trial evaluated 351 adults with inadequately controlled T1DM who were administered canagliflozin 100 mg, canagliflozin 300 mg or placebo as an add-on to insulin. In this treat-to-target study design, the effects of canagliflozin on daily mean glucose, glycemic variability and time spent in target glycemic ranges (glucose >70 to ≤180 mg/dL) were assessed throughout this period. At baseline (week prior to randomization) and at the end of the study, all patients recorded 9-point self-monitoring blood glucose (SMBG) measurements. Additionally, a subset of 89 patients also underwent continuous glucose monitoring (CGM).
At Week 18, reductions in daily mean glucose, standard deviation measured by the 9-point SMBG, reductions in mean glucose and measures of glycemic variability assessed by CGM were seen with both doses of canagliflozin vs. placebo. At the end of the study, canagliflozin 100 mg and 300 mg were associated with a 11.6% and 10.1% increase in the time patients spent within target (glucose >70 to ≤180 mg/dL) and showed comparable reductions in time spent above target (glucose >180 mg/dL) vs. placebo. There were no meaningful changes in the time patients spent below target (glucose ≤70 mg/dL) across groups. Canagliflozin was generally well tolerated, with an increase in serious adverse events related to ketoacidosis.
"These results contribute to our understanding of the potential for canagliflozin to benefit a broad range of patient populations," said James F. List, M.D., Ph.D., Global Therapeutic Head, Cardiovascular & Metabolism, Janssen. "We remain committed to fully exploring how canagliflozin can be used to help patients."
In March 2013, the U.S. FDA approved canagliflozin – INVOKANA® – as a single agent. In two studies comparing INVOKANA® plus metformin to current standard treatments plus metformin – one studying sitagliptin[i] and the other studying glimepiride[ii] – INVOKANA® dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. In the two studies, the overall incidence of adverse events was similar with INVOKANA® and the comparators. INVOKANA® is currently the number-one branded non-insulin type 2 diabetes medication prescribed by U.S. endocrinologists.[iii] It is also the second most common branded therapy prescribed by primary care physicians when adding or switching therapies in patients.[iv] Since its launch, more than 8 million prescriptions have been written for INVOKANA®.[v]
Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in Africa, parts of Asia, Australia, Europe, the Middle East, New Zealand, North America and South America.
INVOKANA® is approved as a single agent in Aruba, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, El Salvador, the European Union (28 countries), Guatemala, Hong Kong, Iceland, India, Israel, Jamaica, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Mexico, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Qatar, Russia, Serbia, Singapore, South Korea, Switzerland, Thailand, United Arab Emirates and the United States.
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 or 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
INVOKANA® can cause important side effects, including:
- Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which 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 pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
- Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or 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. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or 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.
Do not take INVOKANA® if you:
- are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
- have severe kidney problems or are on dialysis
Before you take INVOKANA®, tell your doctor if you have kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; or have other medical conditions.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 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® – used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems).
Possible Side Effects of INVOKANA®
INVOKANA® may cause serious side effects, including:
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA®. Ketoacidosis can be life-threatening and may need to be treated in a hospital. Ketoacidosis can happen with INVOKANA® even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
- Kidney problems. Sudden kidney injury has happened to people taking INVOKANA®. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
- A high amount of potassium in your blood (hyperkalemia)
- Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA®. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting
- 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.
Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture.
The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; 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. 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.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
[i] Lavalle-Gonzalez F, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013 Dec;56(12):2582-92.
[ii] Cefalu T, Leiter L, Yoon K-H, Arias P, Niskanen L, Xie J, Balis D, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50.
[iii] Data on file. Based on NBRx data sourced from IMS NPA Market Dynamics Database, weekly data, showing INVOKANA® has been the leading branded non-insulin type 2 diabetes medication newly prescribed by U.S. endocrinologists for thirty one weeks, through January 2, 2015, the most recent data available at time of approval of INVOKAMET®.
[iv] Data on file. Based on NBRx data sourced from IMS NPA Market Dynamics Database, weekly data through January 2, 2015.
[v] Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, Total Prescriptions, April 2013- April 8th 2016.
SOURCE Janssen Research & Development, LLC