EFFECTS OF PRAMLINTIDE, AN ANALOG OF HUMAN AMYLIN, ON PLASMA-GLUCOSE PROFILES IN PATIENTS WITH IDDM - RESULTS OF A MULTICENTER TRIAL

The effects of subcutaneous administration of 10, 30, or 100 mu g q.i. d. pramlintide, an analog of human amylin, on plasma glucose regulatio n in patients with IDDM were evaluated in a multicenter trial. The pla sma glucose response to a Sustacal test meal was significantly reduced compared with placebo both after 1 week and after 2 weeks of administ ration of 30 or 100 mu g pramlintide. In addition, 24-h mean plasma gl ucose concentrations mere significantly lowered in patients receiving 30 mu g of pramlintide for 2 weeks compared with placebo, while the 10 0-mu g pramlintide dose did not reach statistical significance for the 24-h glucose profiles. At 10 mu g, pramlintide had no effect on the 2 4-h glucose profile or on the plasma glucose response to a Sustacal te st meal. The reduction in 24-h glucose concentrations and glucose conc entrations after the Sustacal test meal observed at the 30-mu g pramli ntide dose was not accompanied by an increased incidence of hypoglycem ic events. The most frequent adverse events were dose-related and invo lved transient upper gastrointestinal symptoms. A majority (>80%) of t he patients who reported these adverse events during week 1 did not re port them in meek 2. These data indicate that pramlintide effectively reduces plasma glucose concentrations as reflected in both a 24-h gluc ose profile and a Sustacal test meal while maintaining an acceptable s afety profile.