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LIPHA METFORMIN TRIAL IN 600 NON-INSULIN DEPENDENT DIABETICS

Executive Summary

LIPHA METFORMIN TRIAL IN 600 NON-INSULIN DEPENDENT DIABETICS is beginning in 20 centers nationwide. The double-blind, randomized, placebo-controlled study is designed to assess safety and efficacy of the hyperglycemia reducing compound in adult diabetic patients whose disease has not been controlled by diet or medication. The participating centers, each of which will enroll 30 patients, began enlisting subjects in October. Under the protocol, patients will be given Upjohn's Micronase for a five-week washout period. Patients adequately controlled by the drug will be dropped from the trial while nonresponders will be randomized to one of three treatment regimens: metformin plus Micronase; metformin and Micronase placebo; or metformin placebo and Micronase. Dosages of the drug will be adjusted for a five-week period and then maintained for six months. Metformin is the chemical cousin of the antidiabetic agent phenformin (Ciba-Geigy's DBI and USV's Meltrol), which was removed from the market under FDA's "imminent hazard" procedural process in 1977. Phenformin was banned because of a high incidence of acidosis. In a press release discussing the study, participating center Georgetown University said that while "accumulation of acid in the blood was a serious problem with phenformin . . . ]it[ rarely occurs with metformin." According to the university, the most common side effects seen with metformin are nausea, diarrhea and loss of appetite. The university noted that metformin "cannot be used in people who have an alcohol dependency, liver or kidney failure or by pregnant women." Established in 1978 to conduct U.S. studies of French parent L'Air Liquide Group drugs marketed in Europe, Lipha Chemicals is also working on development of a drug for Alzheimer's disease and has an antineoplastic agent in Phase I studies at the National Cancer Institute. The company purchased generic solution manufacturer Dey Labs earlier this year ("The Pink Sheet" March 7, T&G-9).
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