Posted at 16th October 2012
written by Michael O’Leary
People with type 2 diabetes who participated in a study using a newly FDA-approved weight-loss drug reduced their blood sugar by an average of 0.4 percent compared to those in the trial who were taking a placebo.
(published site)
(published site)
The researchers reported the results of an analysis they did after the large weight-loss study was completed, and presented them at the European Association for the Study of Diabetes meeting last week in Berlin.
As reported by MedPage Today, the analysis looked at a subset of the 388 people with type 2 diabetes, who were among 2,486 overweight and obese people who took part in the CONQUER study. The 56-week study was designed to test the effectiveness of two doses of the weight-loss drug phetermine/topiramate (Qsymia – pronounced kyoo-sim-EE-uh), which the FDA approved last July.
The analysis of the diabetes patients showed that regardless of the dose they received, their HbA1c fell by an average of 0.4 percentage points compared to a reduction of only 0.1 percent in those who took the placebo. In addition, the average weight-loss for the type 2 diabetes participants was the same as for the nondiabetic participants who took either dose of the drug. Of those on the highest dose, 40 percent lost more than 10 percent their body weight. Of those on the lower dose, 27 percent lost that much weight and only 6 percent of those on placebo lost that much weight.
The researchers noted that the patients with type 2 diabetes in the study appeared to all be at an early stage of the disease with an average baseline HbA1c of 6.8 percent for those in the drug groups and 6.9 percent for those in the placebo group. More than half were not taking metformin. Blood pressure also improved in the drug groups but not by enough to rule out the possibility the lower blood pressure was due to chance.
The analysis did not say whether the data would allow them to determine whether it was the drug or the weight-loss that produced the drop in HbA1c. Nevertheless the researchers concluded that the findings suggest Qsymia may help type 2 diabetics lose weight and improve their HbA1c.
Side effects included constipation, paresthesia or tingling sensations in the skin, and insomnia. These affected less than 20 percent of the participants taking the drug.
Qsymia joins lorcaserin (Belviq®) in becoming the first FDA-approved drugs for weight loss since Xenical® was approved in 1999 and its over-the-counter version sold as Alli® was approved in 2007.
The CONQUER study and the type 2 diabetes analysis were funded by Vivus, the pharmaceutical company that makes Qsymia.
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