PT  - JOURNAL ARTICLE
AU  - Thomas, Robert G
AU  - Peterson, Janet
AU  - Gottlieb, Alan
AU  - Mullane, John
TI  - Effects of Pramlintide, an Analog of Human Amylin, on Plasma Glucose Profiles in Patients With IDDM: Results of a Multicenter Trial
AID  - 10.2337/diab.46.4.632
DP  - 1997 Apr 01
TA  - Diabetes
PG  - 632--636
VI  - 46
IP  - 4
4099  - http://diabetes.diabetesjournals.org/content/46/4/632.short
4100  - http://diabetes.diabetesjournals.org/content/46/4/632.full
SO  - Diabetes1997 Apr 01; 46
AB  - 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.