Some of the biggest changes in the diabetes market in 2011 had to do with medicines — several long-awaited new drugs gained FDA approval, and important labeling changes were made to some diabetes drugs already on the market. In addition, new devices were introduced to make handling needles easier, improve blood glucose control, and provide more options to help people manage their diabetes.
Blood glucose meters
Product: EasyMax Light, EasyMax Voice (second generation), EasyPlus T2
Manufacturer: Oak Tree International Holdings, Inc.
What it does: Oak Tree’s family of meters share many similarities: The no-code EasyMax Light, EasyMax Voice, and EasyPlus T2 all require a 0.6-microliter blood sample from the fingertips, palms, forearms, or thighs, and return results in 5 seconds. The EasyMax Light and EasyMax Voice can store up to 480 results, and the EasyPlus T2 can store up to 360 results. The EasyMax Voice has a talking function that offers bilingual (English and Spanish) instructions and results.
Availability: Oak Tree meters are available through durable medical equipment providers.
Product: On Call Chosen, On Call Plus
Manufacturer: ACON Laboratories, Inc.
What it does: Both the On Call Chosen and the On Call Plus meters can hold up to 300 results in their memories and can calculate 7-, 14-, and 30-day blood glucose averages. (The On Call Chosen can also provide 60- and 90-day averages.) The On Call Plus requires a 1-microliter blood sample and delivers results in 10 seconds, and the On Call Chosen requires a 0.8-microliter blood sample and returns results in 5 seconds. Both meters can use samples drawn from the fingertips, palms, or forearms. The On Call Plus beeps when enough blood has been applied to the test strip, and again when the result is ready. The On Call Chosen allows the user the option of marking each result with the meal it preceded or followed (breakfast, lunch, or dinner) and can be programmed to deliver reminders to check blood glucose. It also includes a strip ejector, so the user can remove test strips from the meter without having to touch them. Both meters must be coded with each new vial of test strips using a code chip.
Availability: On Call meters are available from many online retailers.
Product: Telcare BGM
What it does: The no-code Telcare BGM requires a 0.8-microliter blood sample from the fingertips, palms, or forearms, and takes 6 seconds to return results. Each result can be tagged with one of ten tags about the time it was taken, and the meter can display a graph of where the result fell in relation to target blood glucose ranges and to the last result recorded. The meter itself can hold up to 300 results in its memory, but all results are wirelessly uploaded in real time to the password-protected MyTelcare.com portal, access to which is free with the meter.
Within MyTelcare, users can sort and graph every blood glucose reading ever taken with the meter in a number of ways, including by time of day and pre- and post-meal. Users can also set reminders in MyTelcare for the meter to deliver, as well as blood glucose targets. They can also give health-care professionals or family members access to their MyTelcare account, allowing them to provide feedback and encouragement. People with iPhones can also take advantage of a mobile version of the MyTelcare portal by downloading a free app, available at www.telcare.com.
Availability: The Telcare BGM will be available through the Telcare Web site by the end of 2011.
Product: BD AutoShield Duo
Manufacturer: BD Medical
What it does: The BD AutoShield Duo is designed to protect people from accidental needle sticks with two different guards — one spring-loaded guard locks over the front of the needle as soon as it is removed from the skin, and a second guard locks over the back end of the needle when it is unscrewed from the pen. The AutoShield Duo needle is 5 millimeters long and fits all insulin pens currently on the market in the United States, as well as pens for other injectable drugs such as exenatide (brand name Byetta) and pramlintide (Symlin).
Availability: The BD AutoShield Duo can be ordered through pharmacies.
Needle disposal device
Product: BD Safe-Clip by Mail
Manufacturer: BD Medical
What it does: This device safely removes needles from insulin syringes and pen needles. It can store 1,500 clipped needles in its reservoir, which BD estimates is approximately a one-year supply. The device can be used with 28- to 31-gauge, 4- to 12.7-millimeter needles. The BD Safe-Clip is not intended for use with lancets. When the Safe-Clip is full, it can be mailed for disposal using the included US Postal Service-approved mailing materials (including prepaid postage).
Availability: The BD Safe-Clip by Mail will be available at pharmacies in 2012.
Product: Spring Universal
Manufacturer: D. Medical Industries, Ltd.
What it does: The Spring Universal infusion set offers a tubing connector that rotates 360 degrees, lowering the risk of the infusion set accidentally pulling out. The 28-gauge insertion needle is retractable, which allows users afraid of needles to avoid seeing it even when inserting it, and the 6- or 9-millimeter, 22-gauge cannula is lubricated with medical-grade silicone. The all-in-one inserter works at the push of a button, with an audible click that tells the user that the needle has been successfully inserted. The Spring Universal also includes its Detach-Detect mechanism, which blocks the flow of insulin if any part of the infusion set base comes loose; this in turn sets off the occlusion alarm on the insulin pump. Tubing comes in lengths of 24″, 31″, and 43″.
Availability: The Spring Universal is available through Edgepark Medical Supplies, at www.edgepark.com.
What it does: Each GlucoPouch contains an ounce of mandarin orange-flavored gel, which delivers 15 grams of fact-acting carbohydrate to treat hypoglycemia. The pouches are designed to be strong, so they don’t burst accidentally, but easy to open, so you can get the treatment you need quickly.
Availability: The GlucoPouch is currently available online from American Diabetes Wholesale (www.americandiabeteswholesale.com), Western Diabetic (www.westerndiabetic.com), and from the GlucoBrands Web store (http://buy.glucobrands.com).
What it does: Acarbose is one of two drugs (the other is miglitol [Glyset]) in the class known as alpha-glucosidase inhibitors, which work by slowing the breakdown of carbohydrate in the digestive system. The drug has been available since 1995 under the brand name Precose, but this year Mylan Pharmaceuticals won approval of a generic version. Acarbose can be taken alone or with other diabetes drugs, including sulfonlyureas (such as glipizide, glyburide, and glimepiride), metformin, and insulin. The drug should be taken three times a day, with the first bite of every meal. Acarbose carries no risk of hypoglycemia. It has been shown to lower HbA1c by about 1 percentage point.
Availability: Acarbose is available in 25, 50, and 100-mg tablets.
Product: Linagliptin (Tradjenta)
What it does: Tradjenta joins sitagliptin (Januvia) and saxagliptin (Onglyza) in the DPP-4 inhibitor class. These drugs block the action of an enzyme called DPP-4. That in turn prolongs the effects of the hormone GLP-1, which are to stimulate the release of insulin, slow stomach emptying, restrict the body’s production of glucose, and protect the pancreas’s remaining beta cells. Tradjenta has not been studied in combination with insulin, and has not been approved for children, for people with Type 1 diabetes, or to treat diabetic ketoacidosis. Tradjenta’s effectiveness is reduced by certain medicines called CYP 3A4 inducers, which include phenobarbitol, modafinil (Provigil), and St. John’s wort, among others. In clinical studies, pancreatitis (inflammation of the pancreas) was reported more often in people taking Tradjenta than in people taking a placebo. Cold-like symptoms were the most commonly reported side effect. Tradjenta can be taken once a day, at any time of day, with or without food.
Availability: Tradjenta is available in 5-mg tablets.
Product: Saxagliptin and metformin extended-release (Kombiglyze XR)
Manufacturer: Bristol-Myers Squibb
What it does: The FDA has approved a combination pill containing combined saxagliptin and extended-release metformin for the treatment of Type 2 diabetes. The two drugs work in different ways — saxagliptin (Onglyza) is a DPP-4 inhibitor, which works in the same way as Tradjenta (see earlier explanation), and extended-release metformin (Glucophage XR and others) works by decreasing the amount of glucose produced by the liver and by improving insulin sensitivity.
People with metabolic acidosis (excessive acidity of the blood) or who drink alcohol excessively should not take Kombiglyze XR. The drug is not recommended for people with liver problems. Metformin in any formulation raises a person’s risk of developing lactic acidosis, a rare but potentially fatal side effect.
Availability: Kombiglyze XR is available in tablets of 5 mg saxagliptin/500 mg metformin, 5 mg saxagliptin/1,000 mg of metformin, and 2.5 mg of saxagliptin/1,000 mg of metformin, and should be taken once daily with food.
Drug labeling changes
Product: Colesevelam HCL (Welchol for Oral Suspension)
Reason for label change: Welchol is prescribed for blood glucose control in people with Type 2 diabetes and to lower LDL (low-density lipoprotein, or “bad”) cholesterol. The FDA has recently expanded dosing options for Welchol Oral Suspension to allow people taking the drug to dissolve their doses — one 3.75-gram packet once daily or one 1.375-gram packet twice daily — in 4 to 8 ounces of diet soda or fruit juice. The original guidelines stated the drug could only be taken with water.
Product: Humalog (insulin lispro injection [rDNA origin])
Reason for label change: The FDA has issued several labeling changes to the Humalog label: People using Humalog in a pump can now use the insulin in the pump’s reservoir for up to seven days and should change infusion sets and insertion sites every three days. Before the label change, both the insulin in the reservoir and the insertion sites needed to be replaced every two days.
Product: Humulin R (insulin regular) U-500
Reason for label change: Lilly, the manufacturer of Humulin R U-500, changed that drug’s label to prevent confusion with Humulin R U-100. U-500 insulin is five times as concentrated as U-100 insulin, the type used by most people in the United States. U-500 vials are now marked with a band of diagonal brown stripes, while the U-100 vials have no stripes. “U-500” is now also highlighted in red on the label.
Product: Pioglitazone (Actos, ActoPlus Met, ActoPlusMet XR, Duetact)
Reason for label change: The FDA has decided that the labels for the Type 2 diabetes drug pioglitazone (and combination drugs that include pioglitazone) should carry a warning that use of the drug for more than a year may increase a person’s risk of developing bladder cancer. The FDA’s 5-year interim review of a 10-year study on the relationship between the pioglitazone and bladder cancer found that people taking the drug were 1.4 times as likely to develop bladder cancer than people taking a placebo. The new label warns of that risk, and recommends that people who have or have a history of bladder cancer avoid the drug. It also urges people taking pioglitazone to watch for symptoms of bladder problems, such as blood in the urine or painful urination.
Product: Rosiglitazone (Avandia, Avandamet, Avandaryl)
Reason for label change: In late 2010, the FDA announced severe restrictions on the prescribing of the Type 2 diabetes drug rosiglitazone, due to the higher risk of heart attack associated with the drug. These restrictions, which state that doctors can only prescribe rosiglitazone if all other diabetes drugs have failed to achieve blood glucose control, have this year been added to the drug’s label and Medication Guide (the paper handout that comes with a prescription drug when, among other reasons, the FDA determines it carries a health risk or side effect that people taking it need to know about). The Medication Guide also now includes detailed information about the cardiovascular risks involved with taking rosiglitazone.
Product: Saxagliptin (Onglyza)
Reason for label change: The FDA approved a labeling update to Onglyza that reflects the results of further research on the suitability of the drug for people with Type 2 diabetes who also have severe kidney damage or end-stage kidney disease. Drug information for Onglyza now includes a recommended dose that people with serious kidney problems can take safely, but states that these people should have their kidney function tested before starting Onglyza and periodically while taking the drug.
Product: FreeStyle Navigator
Manufacturer: Abbott Laboratories
Reason for discontinuation: Abbott Laboratories has discontinued its FreeStyle Navigator continuous glucose monitor in the United States due not to safety issues with the product, but to problems fulfilling demand for the product and providing replacement parts under warranty. The FreeStyle Navigator will remain in production outside the United States. For its US customers, the company is providing help transitioning to other glucose monitoring options until March 2012. Abbott recommends that people currently using the product call the customer support number (above) for specific information about available options.