The effects of subcutaneous administration of 10, 30, or 100 μg q.i.d. pramlintide, an analog of human amylin, on plasma glucose regulation in patients with IDDM were evaluated in a multicenter trial. The plasma glucose response to a Sustacal test meal was significantly reduced compared with placebo both after 1 week and after 2 weeks of administration of 30 or 100 μg pramlintide. In addition, 24-h mean plasma glucose concentrations were significantly lowered in patients receiving 30 μg of pramlintide for 2 weeks compared with placebo, while the 100-μg pramlintide dose did not reach statistical significance for the 24-h glucose profiles. At 10 μg, pramlintide had no effect on the 24-h glucose profile or on the plasma glucose response to a Sustacal test meal. The reduction in 24-h glucose concentrations and glucose concentrations after the Sustacal test meal observed at the 30-μg pramlintide dose was not accompanied by an increased incidence of hypoglycemic events. The most frequent adverse events were dose-related and involved transient upper gastrointestinal symptoms. A majority (>80%) of the patients who reported these adverse events during week 1 did not report them in week 2. These data indicate that pramlintide effectively reduces plasma glucose concentrations as reflected in both a 24-h glucose profile and a Sustacal test meal while maintaining an acceptable safety profile.
Effects of Pramlintide, an Analog of Human Amylin, on Plasma Glucose Profiles in Patients With IDDM: Results of a Multicenter Trial
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Robert G Thomas, Janet Peterson, Alan Gottlieb, John Mullane; Effects of Pramlintide, an Analog of Human Amylin, on Plasma Glucose Profiles in Patients With IDDM: Results of a Multicenter Trial. Diabetes 1 April 1997; 46 (4): 632–636. https://doi.org/10.2337/diab.46.4.632
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