Fda approves new type 2 diabetes drug januvia,gl arbeitsbl?tter 5.klasse,can diabetic patient eat onion - Downloads 2016

Three new Type 2 therapies for diabetes from Takeda have been given approval by the US Food and Drug Administration (FDA).
It has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCI) for the treatment of the condition. NESINA is a depetidyl peptidase-4 inhibitor that is created to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinitropic peptide).
On the other hand, OSENI is the first product in the US to feature a DDP-4i and a hiazolidinedione (TZD) in a single tablet, whereas KAZANO merges alogliptin with metformin HCI in one tablet. The most common adverse events reported with NESINA include nasopharyngitis, headache and upper respiratory tract infection, while negative reactions to OSENI range from nasopharyngitis to back pain and upper respiratory tract infection. With regard to KAZANO, side effects such as upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection have been found to take place. Type 2 diabetes is currently the most common form of the disease and affects millions of people around the world. In the US alone, 23 million people currently live with the condition, with multiple medications often needed to help them manage their blood glucose levels, highlighting the severe nature of the disease.
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000The FDA has approved Janssen Pharmaceutical’s new type 2 diabetes treatment, Invokana (canagliflozin). Invokana is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Janssen also will offer a dedicated Invokana CarePath support program to patients and caregivers.
The new drug application for Invokana was based on a comprehensive global Phase 3 clinical program, which enrolled 10,285 patients in nine studies and is one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. The Diabetes Media Foundation is a 501(c)(3) tax-exempt nonprofit media organization devoted to informing, educating, and generating community around living a healthy life with diabetes.
FDA Advisory Panel votes 8-2 in favor of an insulin dosing label update for Dexcom's G5 CGM! On August 1, the FDA announced approval of Boehringer Ingelheim (BI) and Lilly’s SGLT-2 inhibitor Jardiance (empagliflozin). As with other SGLT-2 inhibitors, Jardiance’s main side effects are genital tract infections (6% of people with type 2 diabetes on Jardiance developed a genital infection, compared to 2% of those on placebo). Our mission is to help individuals better understand their diabetes and to make our readers happier & healthier.
Our mission is to help individuals better understand their diabetes and to make our readers happier and healthier. Ridgefield, CT, and Indianapolis, IN, May 2, 2011– Boehringer Ingelheim Pharmaceuticals, Inc. TRADJENTA belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). TRADJENTA 5 mg once daily was approved based on a clinical trial program which included approximately 4,000 adults with type 2 diabetes. Treatment with Tradjenta™ (linagliptin) tablets also produced significant reductions in fasting plasma glucose (FPG) compared to placebo, when used as monotherapy and in combination with metformin, sulfonylurea or pioglitazone. In controlled studies, change from baseline in body weight did not differ significantly between groups when TRADJENTA was administered as monotherapy, in combination with metformin or in combination with metformin plus sulfonylurea.
Adverse reactions reported in greater than or equal to five percent of patients treated with TRADJENTA and more commonly than in patients treated with placebo included nasopharyngitis.
The FDA approval of TRADJENTA marks the first regulatory milestone since the formation of the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance in January 2011. The overall clinical development program for TRADJENTA consists of 30 studies completed, underway or planned.
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257. About DiabetesApproximately 25.8 million Americans1 and an estimated 220 million people worldwide2 have type 1 and type 2 diabetes. What are TRADJENTA tablets?TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). Who should not take TRADJENTA?Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA. Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. What should I tell my doctor before taking TRADJENTA?Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin. Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.


Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed. What are the possible side effects of Tradjenta™ (linagliptin) tablets?The most common side effects of TRADJENTA include stuffy or runny nose and sore throat. For more safety information, please see Patient Information and full Prescribing Information. Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on four pipeline compounds representing several of the largest treatment classes. As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. About Eli Lilly and CompanyLilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. About Lilly DiabetesFor more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. This press release contains forward-looking statements about Tradjenta™ (linagliptin) tablets for the treatment of type 2 diabetes. On February 4, Dexcom announced FDA approval of the G4 Platinum CGM for children 2-17 years old in the United States.
The pediatric version of the G4 Platinum will have an identical sensor to the adult CGM, and the only difference will be two additional warning screens included for extra safety.
Last July, Dexcom also filed for FDA approval of the Dexcom Share remote monitoring system; a response is expected from the agency in the first half of 2014.
Following an FDA advisory committee’s recommendation last December (see New Now Next in diaTribe #28), the FDA announced earlier this month that it has approved the use of the LAP-BAND weight-loss device in individuals with significantly lower body-mass indexes (BMI) than previously allowed. Get your products and services in front of 10,000+ readers globally with Print, email and web promotional activity.
Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH).
As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. Invokana has been studied as a single agent (monotherapy), in combination with metformin, and in combination with other glucose-lowering agents, including insulin, in patients who need further glucose control.
The program provides important support and information regarding affordable access, adherence and education. With TRADJENTA, no dose adjustment is recommended for patients with kidney or liver impairment. Included in the program were placebo-controlled studies evaluating TRADJENTA as monotherapy and in combination with the commonly prescribed medications for type 2 diabetes – metformin, sulfonylurea or pioglitazone. Treatment with TRADJENTA produced significant reductions in two-hour post-prandial glucose (PPG) levels compared with placebo as monotherapy and when used in combination with metformin.
Patients treated with TRADJENTA exhibited a significant mean decrease from baseline body weight compared to a significant weight gain in patients administered sulfonylurea (-1.1 kg vs. Hypoglycemia was more commonly reported in patients treated with the combination of TRADJENTA and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away. If you take TRADJENTA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.
This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization.
Dexcom’s G4 Platinum was previously approved in October 2012, but only for patients above 18 years old – learn more about the G4 Platinum in our test drive of the CGM here.
Some younger patients may already use the G4 Platinum “off label,” but it can be difficult to receive access – providers are sometimes hesitant to prescribe off label and reimbursement is more challenging. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2).


Jardiance comes as an oral, once-daily tablet, to be taken as an addition to diet and exercise for adults with type 2 diabetes. While SGLT-2 inhibitors are currently only approved for type 2 diabetes, several studies are also exploring the potential benefits for type 1, and some clinics already prescribe them “off-label” for people with type 1. Food and Drug Administration (FDA) has approved Tradjenta™ (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA showed statistically significant A1C reductions of up to 0.7 percent when used as monotherapy (compared to placebo). FPG is used to determine glucose levels in a fasting state (usually upon wakening in the morning), and PPG is used to determine glucose levels after meals (usually two hours after eating).
The incidence of hypoglycemia was similar to placebo when TRADJENTA was administered as monotherapy or in combination with metformin or pioglitazone. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA.
By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.
Lilly is also committed to providing solutions beyond therapy – practical tools, education, and support programs to help overcome barriers to success along the diabetes journey.
There is no guarantee that future study results and patient experience will be consistent with study findings to date or that TRADJENTA will be commercially successful. It is great news to hear about more choices for children and teenagers interested in CGM, since the technology is so beneficial for avoiding hypoglycemia and improving time in range. As a reminder, Share will use a cradle to send G4 Platinum CGM data and alerts to an app on up to five selected recipients’ smartphones. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.
Invokana selectively inhibits SGLT2, and as a result promotes the loss of glucose in the urine, lowering blood glucose levels in adults with type 2 diabetes. The most common adverse events with Invokana are genital mycotic (fungal) infections, urinary tract infections and increased urination.
We expect to see multiple SGLT-2 inhibitors approved for type 1 diabetes in the next few years.
TRADJENTA lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day. Pancreatitis was reported more often in patients randomized to TRADJENTA (one per 538 person-years versus zero in 433 person-years for comparator).
Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, or feeling jittery.
For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. The recently approved MiniMed 530G with Enlite CGM is only labeled for people 16 years and older, although patients 7-15 years old can use the Medtronic Paradigm Revel system with Sof-sensor. Leaving comments on product information and articles can assist with future editorial and article content. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies.
A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. In the initial combination of TRADJENTA plus pioglitazone, significant reductions in A1C of 0.5 percent were observed compared to placebo.
The device should offer peace of mind to parents and caregivers, especially when children are at school and when loved ones are traveling alone. For obese people with diabetes, this makes it much easier to use the LAP-BAND, assuming their healthcare team supports them.
TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).
Dexcom’s first insulin pump integration – the Animas Vibe – is also currently under FDA review. A US launch could hopefully occur this year if no major regulatory roadblocks are encountered. Although these results are encouraging, we note that with many weight-loss therapies, the amount of weight loss sustained declines over time. Thus, we look forward to hearing updates on the trial, which will track the safety and efficacy of the LAP-BAND over a five-year period. In light of the FDA’s recent decisions not to approve several new diabetes and obesity drugs (including Bydureon, Linjeta, Afrezza, Qnexa, Contrave, and Lorqess), this approval is a rare regulatory victory.



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