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 administration of pramlintide, a synthetic analog of human amylin, on metabolic control in patients with type 2 diabetes using insulin. RESEARCH DESIGN AND METHODS-Serum fructosamine, HbA(1c), and fasting plasma lipids were measured in 203 patients in a randomized double-blind placebo-controlled 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 significant reductions in serum fructosamine concentrations were observed in the 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) compared with the placebo group (3.5 +/- 3.8 mu mol/l). There were also statistically significant shifts in the proportion of patients with an abnormal serum fructosamine concentration at baseline that normalized at 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 statistically 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 group (0.27 +/- 0.08%). Total cholesterol concentrations were also statistically significantly reduced in both the pramlintide 60 pg t.i.d. group (8.4 mg/dl, P < 0.01) and 60 mu g q.i.d. group (10.5 mg/dl, P < 0.01) 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 statistical significance. The incidence of hypoglycemia was similar in all treatment groups. CONCLUSIONS - Reductions in serum fructosamine, plasma total and LDL cholesterol concentrations, and HbA(1c) support the hypothesis that pramlintide may improve metabolic control in patients with type 2 diabetes using insulin.