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Empagliflozin had similar overall adverse event rates Genital infections were only reported with empagliflozin, at a rate of 4. The once-daily dosing of empagliflozin was well-tolerated and was associated with significantly decreased levels in HbA 1c , decreased fasting blood glucose, and decreased body weight in poorly controlled patients with type 2 diabetes who had been receiving metformin monotherapy. Empagliflozin was also investigated as an add-on to pioglitazone with or without metformin in patients with type 2 diabetes in a week trial. Finally, similar proportions of patients reported adverse events with empagliflozin Confirmed hypoglycemia was reported by 1.
A special population trial was also conducted to determine the efficacy and tolerability of empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus. Empagliflozin has been studied with other therapies, such as for lipid control with simvastatin, in healthy volunteers. The pharmacokinetic results suggest that no dose adjustments for either drug are necessary when empagliflozin and simvastatin are coadministered. Ipragliflozin Suglat is an SGLT-2 inhibitor that gained regulatory approval in Japan in January for the treatment of patients with type 2 diabetes, but is not yet approved by the FDA.
Ipragliflozin has been studied in 6 phase 3 clinical trials in Japan and has demonstrated significant reductions in HbA 1c , decreases in FPG, and decreases in total body weight without many adverse events. All the clinical trials were conducted in Japan, because the manufacturer decided to focus on the Asian market for ipragliflozin. Tofogliflozin CSG is an investigational, potent, and highly selective SGLT-2 inhibitor that is currently in phase 3 clinical trials.
The SGLTs have several functions in the body. The inhibition of SGLTs that are not involved in renal glucose absorption would lead to undesirable side effects. Therefore, the high selectivity of tofogliflozin to SGLT-2s, if approved by the FDA, is expected to play an important role in terms of safety. Incretins are hormones that are secreted by cells in the small intestine during an oral nutrient load. Glucagon-like peptide-1 GLP-1 is an incretin that has potent antihyperglycemic effects.
In the presence of hyperglycemia, GLP-1 causes the release of insulin from the pancreas, shuts down glucagon secretion, slows down gastric emptying, and acts on the hypothalamus to increase satiety. The first 3 of these GLP-1 drugs recently had significant marketing changes. The new exenatide extended-release for injectable suspension pen Bydureon that was approved by the FDA for the treatment of type 2 diabetes on March 3, , is a prefilled, single-use, once-weekly pen injector. It provides the same continuous supply of the drug as the original formulation, but the new pen is designed to be more user-friendly.
Patients attach the needle, twist the base of the pen to mix the drug, then tap the pen firmly against the palm of their hand for 80 times or more, while rotating the pen until the solution is completely mixed. Each weekly dose in the pen is made up of microspheres that house exenatide and slowly dissolve over the span of a week. It requires no titration and can be administered at any time of the day, with or without meals. The exenatide extended-release pen improves glycemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
The original single-dose tray version of Bydureon has been shown to provide powerful HbA 1c reduction and weight loss. Albiglutide Tanzeum subcutaneous injection is a long-acting GLP-1 receptor agonist approved by the FDA in April as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The dose may be increased to 50 mg once weekly if the glycemic response is inadequate.
As a once-weekly subcutaneous injection, it requires fewer injections than short-acting GLP-1 agonists. HARMONY 2 demonstrated the efficacy of albiglutide as monotherapy in a week, randomized, double-blind, placebo-controlled multicenter trial. A study extension to 3 years revealed a durable reduction in HbA 1c. In the longest duration comparative study of albiglutide to date, HARMONY 3 compared the efficacy and safety of albiglutide versus sitagliptin, glimepiride, and placebo in patients whose glycemic levels were inadequately controlled with metformin.
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There were no reports of severe hypoglycemia in the albiglutide arm. In a week, randomized, open-label, noninferiority study, HARMONY 4 compared albiglutide with insulin glargine in patients receiving metformin with or without a sulfonylurea. Albiglutide has also been studied as an add-on therapy to other drugs, including pioglitazone.
In HARMONY 1, patients whose glycemic control was inadequate with pioglitazone, with or without metformin, were administered either albiglutide 30 mg or placebo. Weight changes were not significantly different between the 2 groups. Adverse reactions of nausea and vomiting were comparable between the albiglutide and the placebo groups, but were higher with albiglutide than with placebo in diarrhea Finally, as a new member of the GLP-1 drug class, it is important to compare albiglutide with other drugs in this class. HARMONY 7 was a week, randomized, open-label noninferiority phase 3 clinical trial comparing albiglutide with liraglutide in patients with uncontrolled type 2 diabetes.
OTHER SANOFI TREATMENTS?
In addition, patients in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than patients in the liraglutide group. The FDA approved dulaglutide Trulicity as a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes on September 18, The recommended starting dose is 0. Dulaglutide has also been studied as a monotherapy versus metformin in patients with uncontrolled type 2 diabetes. Nausea, diarrhea, and vomiting were the most common adverse events and occurred at similar rates in both the dulaglutide and metformin treatment groups.
No severe hypoglycemia was reported. Technosphere insulin human Afrezza is a recombinant regular human insulin inhalation powder approved by the FDA in June for the treatment of type 1 and type 2 diabetes mellitus. When the insulin is inhaled through the device, the powder is aerosolized and delivered to the lung. Afrezza should be administered at each mealtime and is touted as an alternative to injectable short-acting insulin.
The pharmacokinetics for the powder was studied in 11 healthy nonsmokers who were randomized to either a dose of single inhalation consisting of 25 U, 50 U, or U of inhaled human insulin or to a fixed dose of 10 IU of regular human insulin. When comparing the 2 groups, it was noted that the inhaled insulin achieved peak concentration approximately 2 hours earlier than the regular human insulin. The pharmacokinetics measured by the area under the curve was found to be linear with the doses that were studied.
No treatment-related adverse events were reported with the inhaled human insulin. It was concluded that this inhaled regular insulin had a more rapid absorption than the subcutaneous regular human insulin with linear pharmacokinetics. The regular human insulin inhaled powder has been studied in patients with type 1 and type 2 diabetes.
Across a broad spectrum of diabetes severity, inhaled human insulin was noninferior to active comparators in 2 of 3 trials and was superior to placebo in HbA 1c reduction, as was demonstrated in week to week clinical trials. A total of patients receiving inhaled insulin with a basal insulin dose of glargine were compared with patients receiving biaspart insulin given twice daily in patients with type 2 diabetes mellitus.
The between-group difference was 0.
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The inhaled insulin group demonstrated fewer adverse events of mild-to-moderate and severe hypoglycemic events and significantly less weight gain. The safety profiles of the drugs were similar, except the inhaled insulin demonstrated an increase in forced expiratory volume in 1 second FEV1 and an increase in the occurrence of cough.
The FDA has approved the medication with a box warning that states that inhaled human insulin may cause acute bronchospasm and is not recommended for use by patients with asthma or chronic obstructive pulmonary disease. Other common side effects include throat pain or irritation 4. Ranolazine is a novel antiangina drug used in the treatment of patients with chronic angina, and has also been shown to lower HbA 1c and FPG levels in clinical trials.
Ranolazine inhibits the cardiac late-phase sodium current during cardiac repolarization, thus improving sodium-calcium homeostasis and resulting in reduced myocardial ischemia. The double-blind study included patients with non—ST-segment elevation myocardial infarction acute coronary syndrome and at least 1 indicator of moderate-to-high risk of a recurrent ischemic event who were randomized in a 1: Ranolazine had a placebo-adjusted reduction in HbA 1c of 0.
In addition, ranolazine also had a placebo-corrected reduction in FPG of The exact mechanism of the reduction of HbA 1c with ranolazine is not known, but experimental models have suggested that ranolazine increases glucose-stimulated insulin secretion in isolated pancreatic islet cells. Many patients with diabetes have concurrent nephropathy. In patients with chronic kidney disease, sevelamer is used in the management of hyperphosphatemia. Sevelamer is also a bile sequestrant in addition to being a phosphate binder.
Thus, sevelamer's effect on HbA 1c is possibly related to its bile acid—binding ability.
The problem of diabetes in the United States will continue to wreak heavy human and financial tolls. The complications stemming from diabetes will continue to climb if they are not stemmed. The most common obstacle a physician faces in clinical practice is patient adherence. Aside from efficacy and safety, the common themes seen with these new and emerging drugs are the convenience of administration and the convenient dosing frequency. All the oral drugs discussed in this review article are once-daily medications, with the exception of ranolazine.
All new injections for diabetes are coming out in a pen format to improve patient adherence. A new inhaled insulin was found to work more quickly than the injectable version of the drug, and it has shown to be as effective as other short-acting subcutaneous insulin agents. Perhaps the most exciting aspects of these novel developments in diabetes management are that the new agents are either weight-friendly or can induce weight loss, or they have lower risks for hypoglycemia.
Weight gain in patients with diabetes is counterproductive, because substances related to insulin resistance are upregulated in obese patients. Postmarketing data are continuing to be collected for these drugs to address safety concerns. No macrovascular outcomes data are currently available for the antidiabetes drugs that are mentioned in this review, although each drug will have to conduct a dedicated CV safety trial to meet the updated FDA guidance recommendations.
The risks and benefits of each drug should be appropriately weighed when a diabetes regimen is chosen for a particular patient.
New and Emerging Drugs and Targets for Type 2 Diabetes: Reviewing the Evidence
Dr Miller, Dr H. Nguyen, Dr Hu, and Dr Lin reported no conflicts of interest. Nguyen is on the Speaker's Bureau for AstraZeneca. The passage of the Accountable Care Act in is driving improved accountability for quality through the establishment of accountable care organizations ACOs.
ACOs provide incentives for healthcare providers to improve the quality of care delivered in physicians' offices, hospitals, and long-term care settings. Even with multiple efforts to improve diet and exercise, pharmacologic treatments continue to be essential to improving the quality of care and minimizing the costs associated with the severe complications of type 2 diabetes in the short term and the long term. In the past, when oral agents failed in patients with diabetes, the only option was the initiation of injectable insulin.
But the introduction of new medications that work through different mechanisms of action, alone or in combination, to control hyperglycemia has changed that approach. In their article, Miller and colleagues describe some of these new and emerging drugs and targets for treating type 2 diabetes.
Clinically meaningful improvements in outcomes will not be achieved, however, until patient adherence is improved. Adherence is a major problem in patients with type 2 diabetes. What are the plans for the consumer healthcare business? Dineout GIRF is live: Read Post a comment. Login from existing account Facebook Google Email. Share on Facebook Share on Twitter. All Comments Your Activity.
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Business FDI in e-commerce: Firms oppose extension of Feb 1 deadline Featured Today In Travel. Buyers' returns spoil vendors' ecomm party. Avandia rosiglitazone is a member of the thiazolidinediones drug class and is commonly used for Diabetes - Type 2 and Nonalcoholic Fatty Liver Disease. This Avandia price guide is based on using the Drugs. Prices are for cash paying customers only and are not valid with insurance plans. Avandia is available as a brand name drug only, a generic version is not yet available.
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