PRAMLINTIDE, A SYNTHETIC ANALOG OF HUMAN AMYLIN, IMPROVES THE METABOLIC PROFILE OF PATIENTS WITH TYPE-2 DIABETES USING INSULIN

OBJECTIVE - To examine the effects of 4 weeks of subcutaneous administ ration of pramlintide, a synthetic analog of human amylin, on metaboli c control in patients with type 2 diabetes using insulin. RESEARCH DES IGN AND METHODS-Serum fructosamine, HbA(1c), and fasting plasma lipids were measured in 203 patients in a randomized double-blind placebo-co ntrolled parallel-group multicenter trial using doses of 30 mu g q.i.d ., 60 mu g t.i.d., and 60 mu g q.i.d. RESULTS - Statistically signific ant reductions in serum fructosamine concentrations were observed in t he pramlintide 30 mu g q.i.d. group (17.5 +/- 4.9 mu mol/l, P = 0.029) , the pramlintide 60 pg t.i.d. group (24.1 +/- 4.9 mu mol/l, P = 0.003 ),and the 60 mu g q.i.d. group (22.6 +/- 4.1 mu mol/l, P = 0.001) comp ared with the placebo group (3.5 +/- 3.8 mu mol/l). There were also st atistically significant shifts in the proportion of patients with an a bnormal serum fructosamine concentration at baseline that normalized a t week 4 within the pramlintide 60 mu g t.i.d. group and the 60 mu g q .i.d. group. Consistent with the fructosamine results, there were stat istically significant reductions in HbA(1c) in the pramlintide 30 mu g q.i.d. group (0.53 +/- 0.07%, P = 0.0447), the pramlintide 60 mu g t. i.d. group (0.58 +/- 0.07%, P < 0.0217), and the pramlintide 60 mu g q .i.d. group (0.51 +/- 0.08%, P = 0.0242) compared with the placebo gro up (0.27 +/- 0.08%). Total cholesterol concentrations were also statis tically significantly reduced in both the pramlintide 60 pg t.i.d. gro up (8.4 mg/dl, P < 0.01) and 60 mu g q.i.d. group (10.5 mg/dl, P < 0.0 1) compared with placebo (1.2 mg/dl). Body weight decreased in both of the pramlintide 60 mu g groups, but the trend did not achieve statist ical significance. The incidence of hypoglycemia was similar in all tr eatment groups. CONCLUSIONS - Reductions in serum fructosamine, plasma total and LDL cholesterol concentrations, and HbA(1c) support the hyp othesis that pramlintide may improve metabolic control in patients wit h type 2 diabetes using insulin.