REPAGLINIDE AND TROGLITAZONE IN TREATMENT OF TYPE II DIABETES MELLITUS

$0M01FY2000RRNIH

Washington University, Saint Louis MO

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Abstract

This is an open, randomized, controlled, parallel group study. First Phase: Following a four-week washout, subjects will be randomized to study therapy and enter a 14 week period in which dose will be escalated to a fixed, submaximal dose of each drug or their combination, after which HbA1c will be evaluated and will be evaluated and response rate determined. An analysis will be performed at this stage. Second Phase: An 8 week period in which subjects who have an FBG greater than or equal to 120mg/dl are titrated until maximal dose of each drug. Third Phase: Subjects who do not achieve target control when treated with Troglitazone on maximal dose in monotherapy will receive a Test Dose of Repaglinide and subsequently be treated with combination therapy, including a titration period and a stabilization period and a stabilization period to a total of 10 weeks.

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