Issue 19, May 2010
7. Diabetes Medicine Updates

GLP-1 analogue taspoglutide meets its end point

     A new diabetic drug of GLP-1 analogue class from Roche and Ipsen meets its end point. Patients who took 10 mg or 20 mg of the drug taspoglutide got better HbA1c test results than those who took placebo. The phase 3 study, called "T-emerge 3," involves 326 patients taking taspoglutide or placebo on top of Takeda's Actos (pioglitazone) and metformin.

Sitagliptin again wins the test for safety and tolerability

    A study was conducted to update the safety and tolerability assessment of sitagliptin by pooling data from 19 double-blind clinical studies. The 19 studies assessed sitagliptin taken as monotherapy, initial combination therapy with metformin or pioglitazone, or as add-on combination therapy with other antihyperglycemic agents

     In a previous pooled analysis of 12 double-blind clinical studies that included data on 6,139 patients with type 2 diabetes, treatment with sitagliptin, was shown to be generally well tolerated compared to treatment with control agents. The purpose of the present analysis was to update those parameters. The present study results showed that summary measures of overall adverse events were similar in the sitagliptin and non-exposed groups, except for an increased incidence of drug-related adverse events in the non-exposed group. Incidence rates of specific adverse events were also generally similar between the two groups. Treatment with sitagliptin was not associated with an increased risk of major adverse cardiovascular events. So it was concluded that sitagliptin 100 mg/day was generally well tolerated in clinical trials of up to 2 years in duration.

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GnRH Agonists Used to Treat Prostate Cancer may produce Diabetes

     Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. So FDA has notified the health care professionals its findings. GnRH agonists are the class of drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.

     According to FDA Healthcare professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. FDA recommends that patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease, due to the increased risk. The complete details as well as the notification are available at

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