Tag Archives: diabetes drug

Combination of Diabetes Drug and Exercise found to Be Less Effective


Researchers have shown that exercise can help people who have type 2 diabetes but according to the researchers of University of Alberta, they looked at the two impacts of exercise and metformin and the result was less beneficial.

Dr. Normand Boule, an Associate Professor in the Faculty of Physical Education and Recreation at the University of Alberta said that the study involves three objectives which includes looking for the effect og metformin on exercise among those who have diabetes. Next is to examine the effect of exercise on metformin concentrations in the body, and lastly to look for the effect of both exercise and metformin on glucose control.

On the study, they recruited ten men and women between the age 30 and 65 with type 2 diabetes but does not take medications that lowers the glucose or insulin.

Boule said that as expected in their study, metformin lowered the blood glucose concentrations that were measured during two hour period after lunch. But, they also found out that on the non-exercise day, metformin led to better glucose control after lunch compared on the day their participants took metformin and exercise.

“Boule thinks that because both metformin and exercise act to lower glucose levels, the combination may have triggered a counter regulatory response by the body to prevent glucose levels dipping too much. This study was recently published in the journal Diabetes Care.” http://www.medindia.net/news/Less-Benefit-Seen-With-Combination-of-Diabetes-Drugs-With-Exercise-89473-2.htm

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Diabetes Drug Needs More Safety Data for the Market Approval

Diabetes Drug Needs More Safety Data for the Market Approval


A new study on the experimental diabetes drug should have safety data to win the approval of U.S market said by Shares of Amylin Pharmaceuticals Inc. traded higher Friday as analysts.

According to the report of the company late Thursday, their once-per-week medication Bydureon does not influence electrical activity of the heart, a key safety fear for diabetes drugs. The Food and Drug Administration refused approval for the drug in October, asking for more information about the drug’s heart safety.

“Jefferies analyst Thomas Wei said in a note that the study “puts Bydureon back on track for U.S. regulatory approval,” which he expects in the first quarter of 2012. Amylin expects to resubmit the drug to FDA in the third quarter of this year” http://www.businessweek.com/ap/financialnews/D9OBJGDO0.htm

Bydureon is intended to be a next-generation side of the twice-daily injection Byetta, which is at present marketed by Amylin and Eli Lilly & Co. of Indianapolis. Alkermes, based in Waltham, Mass., produced the technology that slowly liberates the drug over the track of a week.

Companies said Thursday a 75-patient study of Bydureon demonstrates it did not hinder with the QT period, which is the time it takes the heart to recalibrate its electrical signal ahead of pumping period.

Some analysts are still gambling against Bydureon’s success in spite of the safety guarantee. William Blair & Co. analyst John Sonnier preserved a “Market Perform” rating on Amylin citing “the doubt concerning Bydureon’s commercial success.”

Prior this year the companies reported unsatisfactory results for Bydureon in a head-to-head study alongside Novo Nordisk’s Victoza, a new diabetes drug that is by now on the market. On standard, Bydureon abridged blood sugar levels in diabetics by less than Victoza, a once-daily injection that uses an unlike device of action.

Bydureon is piece of a new signal of diabetes treatments intended to treat the increasing spate of the disease in the U.S. Though, the FDA has raised security principles for such treatments after GlaxoSmithKline’s blockbuster diabetes pill Avandia was related to heart attack risks.

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Chugai Diabetes Drug Given Up by Roche

Chugai Diabetes Drug Given Up by Roche


“Roche is returning the overseas rights to a drug for type 2 diabetes to its own Japanese unit Chugai Pharmaceutical Co.” http://www.pharmatimes.com/Article/11-07-06/Roche_gives_up_on_Chugai_diabetes_drug.aspx

The drug in issue is CSG452, sodium-glucose cotransporter-2 (SGLT2) inhibitor which was licensed by Roche in January 2007. The firms worked jointly on a global Phase II study but the Swiss major has just reviewed its pipeline, and has resolute to go again the expansion and marketing rights.

According to Chugai, it will find another partner in regards to the overseas development, underway Phase III studies of the complex in Japan in November last year. The Tokyo-headquartered group, which is almost 60%-owned by Roche, added that there is no alter to the plan to file for support in Japan in 2013.

SGLT2 class, a precise goal situated in the kidney, is presently led by AstraZeneca and Bristol-Myers Squibb’s dapagliflozin, which is at this time under reassess at regulators in Europe and the USA.

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Diabetes Drug Pulled Out in Some Countries Due to Cancer Risks

Diabetes Drug Pulled Out in Some Countries Due to Cancer Risks


“ The Drug Administration of Vietnam (DAV) called for doctors to use caution in prescribing a pair of diabetes drugs after a French study linked their long-term use to an increased risk of bladder cancer.” http://www.thanhniennews.com/2010/Pages/20110617115919.aspx

DAV have asked the health centres nationwide to notify the patients with diabetes of the supposed cancer risk to Actos and Competact and to have a close watch for the harmful effects of the drugs.

On June 9, the officials stopped the use of Actos (pioglitazone) and Competact (metformin and pioglitazone) after a study showed an increase risk in the development of bladder cancer among the users. Germany also pulled out the drugs from the market.

After five days, the United States Food and Drug Administration (FDA) warned the consumers that Actos, the diabetes drug, may increase the risk of developing bladder cancer when it is used for more than five years.

FDA also suggests the doctors not to prescribe the Actos to patients who have bladder cancer and to be more alert and cautious on prescribing it to patients who have survived with bladder cancer.

Moreover, according to the agency, the benefits of blood sugar control with pioglitazone should be measure against the unknown risk factor for the recurrence of cancer. The agency also added that diabetes patients should tell their doctor about the symptoms they experience with bladder cancer like blood or red color urine, frequent urination or pain while urinating and pain in back or in lower abdomen.

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Diabetes Drug Linked to Bladder Cancer

Diabetes Drug Linked to Bladder Cancer


FDA informs the public of the possible association between the lengthen use of pioglitazone and the increased risk for bladder cancer after they reviewed the data from the 5-year interim analysis ongoing, 10 year epidemiological study.

On the warnings and precaution section of the label of the drug, it will be updated to add up the information of the risk. Moreover, the medication guide of the patient with the medication will be revised including the information.

Even though there was no overall increased risk in bladder cancer linked to pioglitazone, about 40% increase in diabetes was seen among the patients who were exposed to pioglitazone for 12 months. It also increased the risk to those who were exposed in the highest cumulative level.

“However, the risk for bladder cancer increased as the dose and duration of pioglitazone increased. Being treated with pioglitazone for more than 12 months was associated with a 40% increase in the risk for bladder cancer vs. never being treated with pioglitazone (HR=1.4; 95% CI, 0.9-2.1). After more than 24 months of pioglitazone use, the HR was 1.4 (95% CI, 1.03-2.0) and was of nominal statistical significance. Based on these data, the FDA calculated that duration of therapy for more than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up vs. never use of pioglitazone, according to the press release.” http://www.hemonctoday.com/article.aspx?rid=84851

Now, France suspended the use of pioglitazone because of the results of the epidemiological study recommending the increase risk of bladder cancer with pioglitazone. Germany also suggests starting pioglitazone among new patients.

FDA made recommendations to the healthcare providers; such recommendations are inhibiting the use of pioglitazone among patients with bladder cancer and to use pioglitazone with caution on patients who have history of bladder cancer. The good effect on the blood sugar control with pioglitazone would be weighed against the unknown risks for the recurrence of cancer.

The Endocrine Society, the American Association of Clinical Endocrinologists and the American Diabetes Association are currently advising patients at present taking pioglitazone or any combination of medication that contains pioglitazone, to keep on taking all presently set medications unless if not instructed by their health care provider.

FDA will go on to assess data from the ongoing, 10-year epidemiological study and will also carry out an inclusive reconsider of the results from the French study. The FDA will update the public once more information is available

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