EFFECTS OF 4 WEEKS ADMINISTRATION OF PRAMLINTIDE, A HUMAN AMYLIN ANALOG, ON GLYCEMIA CONTROL IN PATIENTS WITH IDDM - EFFECTS ON PLASMA-GLUCOSE PROFILES AND SERUM FRUCTOSAMINE CONCENTRATIONS

The effects of 4 weeks' administration of pramlintide an analogue of t he human hormone amylin, on blood glucose control in 215 patients with insulin-dependent diabetes mellitus were examined in a 4-week, random ized, double-blind, placebo-controlled, parallel-group trial. Pramlint ide was administered subcutaneously prior to meals in four dosing regi mens: 30 mu g four times per day (breakfast, lunch, dinner, and evenin g snack), 30 mu g three times per day (breakfast, lunch and dinner [BL D]), 30 mu g three times per day (breakfast, dinner and evening snack [BDS]), and 60 mu g twice per day (breakfast and dinner). After 4 week s of pramlintide 30 mu g four times per day administration, there was a statistically significant reduction in the mean 24 h plasma glucose concentration when compared to placebo (-1.4 +/- 0.5 vs 0.3 +/- 0.5 mu mol/l, p = 0.009). Serum fructosamine concentrations were reduced 62 +/- 10 mu mol/l in the pramlintide 30 mg four times per day group, 43 +/- 7 mu mol/l in the pramlintide 30 mu g three times gel-day (BLD) gr oup, 47 +/- 6 mu mol/l in the pramlintide 30 mu g three times per day (BDS) group, 46 +/- 7 mu mol/l in the pramlintide 60 mu g twice per da y group, and 29 +/- 8 mu mol/l by placebo. The incidence of hypoglycae mia was not different in any pramlintide group compared to the placebo group. Nausea, the most frequent adverse event, subsided after the fi rst week of treatment in the majority of patients. In conclusion, pram lintide improved blood glucose control over a 4-week period without in creased hypoglycaemia and was well tolerated. Future studies using a l onger period of pramlintide administration with assessment of HbA(1c) as the measurement of glycaemic control are warranted.