Effect of pramlintide on weight in overweight and obese insulin-treated type 2 diabetes patients.
OBJECTIVE
Several randomized, placebo-controlled, double-blind trials in insulin-treated patients with type 2 diabetes have shown that adjunctive therapy with pramlintide reduces hemoglobin (Hb)A1c with concomitant weight loss. This analysis further characterizes the weight-lowering effect of pramlintide in this patient population.


METHODS
This pooled post hoc analysis of two long-term trials included all patients who were overweight/obese at baseline (BMI > 25 kg/m2), and who were treated with either 120 microg pramlintide BID (n = 254; HbA1c 9.2%; weight, 96.1 kg) or placebo (n = 244; HbA1c 9.4%; weight, 95.0 kg). Statistical endpoints included changes from baseline to week 26 in HbA1c, body weight, and insulin use.


RESULTS
Pramlintide treatment resulted in significant reductions from baseline to week 26, compared with placebo, in HbA1c and body weight (both, p < 0.0001), for placebo-corrected reductions of -0.41% and -1.8 kg, respectively. Approximately three times the number of patients using pramlintide experienced a > or = 5% reduction of body weight than with placebo (9% vs. 3%, p = 0.0005). Patients using pramlintide also experienced a proportionate decrease in total daily insulin use (r = 0.39, p < 0.0001). The greatest placebo-corrected reductions in weight at week 26 were observed in pramlintide-treated patients with a BMI >40 kg/m2 and in those concomitantly treated with metformin (both, p < 0.001), for placebo-corrected reductions of -3.2 kg and -2.5 kg, respectively.


CONCLUSIONS
These findings support further evaluation of the weight-lowering potential of pramlintide in obese patients with type 2 diabetes.
Hollander
Priscilla
P
Baylor College of Medicine, Dallas, Texas, USA.
Maggs
David G
DG
Ruggles
James A
JA
Fineman
Mark
M
Shen
Larry
L
Kolterman
Orville G
OG
Weyer
Christian
C
D000368:Aged; D000682:Amyloid / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D003920:Diabetes Mellitus / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D058228:Islet Amyloid Polypeptide; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009765:Obesity; D010919:Placebos; D015431:Weight Loss
D000682:Amyloid; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D058228:Islet Amyloid Polypeptide; D008687:Metformin; D010919:Placebos; C105254:pramlintide