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Metaglidasen Controls Diabetes and Lipids Without Side Effects
posted June 28, 2005

The diabetes drug metaglidasen was shown to control blood glucose levels without causing weight gain or edema, according to a mid-stage clinical trial.

The oral drug, metaglidasen, is designed to regulate the genes needed to improve insulin sensitivity without activating those responsible for weight gain and fluid retention, according to its developer, Metabolex Inc.

Existing glitazone insulin sensitizers commonly used to treat type 2 diabetes can cause weight gain and edema. "Metaglidasen seems to work as well as these drugs without the safety issues," said Metabolex chief executive Harold Van Wart.

The drug was tested in a phase II trial of 217 patients with type 2 diabetes who were also getting insulin injections. They were given either 200 mg or 400 mg of metaglidasen or a placebo once a day for 12 weeks.

The trial showed that both doses of the drug reduced a measure of glucose control called HbA1c by 1%, compared with 0.3% for the placebo group. Metaglidasen also lowered fasting blood glucose levels by statistically significant margins.

Edema, which occurs in about 15% of patients with type 2 diabetes who are on insulin, was seen in 11% of the lower-dose metaglidasen patients, 5.8% for the higher dose and 16.2% for the group on insulin only. Patients on the drug gained 0.5 kilograms on average, compared with 0.8 kg for the insulin-only group. There were no cases of heart failure, Van Wart said.

The company also said both doses of metaglidasen had no significant effect on liver and muscle enzymes, kidney function or blood cell formation. The phase II study of metaglidasen showed unchanged lipid levels, except for the 400 mg dose, which lowered triglyceride levels by 15%.

Metaglidasen modulates the genes needed for insulin sensitization, but not those responsible for edema and weight gain.
Metabolex is now testing a higher 600-mg dose of the drug in a second phase II trial and expects to launch a phase III study in the second quarter of next year, Van Wart said.

Source: Diabetes In Control.com: ADA 65th Annual Scientific Sessions
Abstract #44-OR. MBX-102: A Novel Non-TZD Insulin Sensitizer that Improves Glycemic Control without Causing Edema or Weight Gain in Patients with Type 2 Diabetes (T2DM) on Concomitant Insulin Therapy. Julio Rosenstock, MD, Fernando Flores-Lozano, MD, Sherwyn Schwartz, MD, Guillermo Gonzalez- Galvez, MD and David B Karpf, MD.

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