The drug, which is considered a DPP-4 inhibitor, is to be taken once a day and potentially in combination with other diabetes drugs. Januvia and Onglyza are in the same class of diabetes drugs. Tradjenta works by blocking a specific type of chemical messenger in the guy in order to cause the body to release more insulin after a meal. The drug does come with potential side-effects, including upper respiratory infection, sore throat, headache, muscle pain and even a stuffy or runny nose.

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The company, which is working with the JDRF, is testing a sensor that it says may provide more reliable blood sugar readings on continuous glucose monitoring systems. The company also says it anticipates bringing new infusion sets to market in the next few years. Those sets would work with insulin pumps.

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 The FDA wants the company to show that the second version of the device is as effective as the first generation of the device. The company had updated its approval application, including the second generation of the device. MannKind says it is currently working on clinical trials that will address some of the FDA’s concerns.

The FDA’s denial is the latest setback for MannKind. The company’s owner, Alfred Mann, has sunk $925 million of his own money into the company to keep it from going under.

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The companies pulled the plug in the drug because it did not meet its primary goal. The companies said that there were no unanticipated safety issues, but that safety monitoring among trial participants is warranted.

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The drug can actually stop and potentially reverse diabetic peripheral neuropathy, which can lead to the death of nerves resulting in circulation problems and potential infections leading to amputation. It can be taken as infrequently as once a week orally and still be effective, the researchers claim. It also can be taken in small doses, reducing the potential side effects.

Researchers say the drug needs to be studied for another year or two and then will hopefully proceed to human trials.

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The FDA’s decision has set the company back and put it behind competitors. However, because of concerns over potential heart-related side effects of the drug, the agency asked for more testing be done. The comp aqany is expected to provide further information by the end of 2011.

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The company earlier signed a deal with CureDM Group Holdings, a company that is working onn experimental drug that aims to restore the body’s insulin production in Type 1 diabetics. It also agreed to buy a Type 2 diabetes treatment which increases insulin production and the production of the hormone GLP-1 from Metabolex. The deals have been aimed at taking on rival Novo Nordisk.  

The firm said it may be looking for replacements for Lantus or a better version of a fast-acting insulin.

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Early data suggests there may be one, but not enough of a link to cause the FDA to pull the drug from the market. When the regulator initially approved the drug, it required Takeda Pharmaceuticals to keep data on a possible link.

The article suggests that no increased risk was found simply from taking the drug. However, in patients taking the drug the longest and accumulating the highest dosage, there appears to be a link. The risk appeared to be the highest among those taking the drug for at least two years.

The FDA says the findings do not prove a link and the article notes that those taking the medication should not stop taking it unless they are advised to do so by their doctors.

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The drug, designed for people with Type 2 diabetes, helps people with diabetes to pass excess glucose and related calories though their urine. This prevents it from building up in the body. Researchers compared patients taking a combination of dapagliflozin to patients taking glimepiride and a placebo. The patients taking the combination involving dapagliflozin had lower blood sugar levels and, lost more weight.

The downside to the drug is that patients taking it are more likely to develop genital tract infections due to the elevated levels of glucose in the urine.

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The three-year arrangement, to be funded by the AstraZeneca, pairs researchers from both the company and university’s Institute of Ophthalmology. The goal is to produce a compound within five years that would then go through clinical trials and possibly on the market in a decade’s time.

The technology could lead either to the development of transplantable material or to methods for stimulating new cell growth in the eye, says Dr. Marcus Fruttiger of UCL, the project’s leader, tells the Guardian.

Most type-1 diabetics will suffer eyesight problems, and 20% to 30% will go blind, according to the Guardian report. At least half of those with type 2 diabetes will also experience retinopathy over their lifetimes.

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