| Results: |
Insulin therapy in type 2 diabetes is often initiated only after failure on multiple oral agents, in part because of the burden of daily injections. To evaluate satisfaction and QOL when initiating insulin earlier using pulmonary delivery with Exubera®, we studied 423 type 2 diabetes subjects from Europe, Africa, Asia and South America, poorly controlled on sulfonylurea monotherapy, and randomized to adding either premeal Exubera®, n = 222 (INH) or metformin, n = 201 (MET) for 24 wks. Randomization was stratified (HbA1c = 8.0-9.5% and > 9.5-12.0%) and medications titrated to goal FPG of 80ϑ140 mg/dL. Patients were 53% male and had mean±SD age = 60±9 yrs, BMI = 28.8±4.4 kg/m², and HbA1c = 9.7±1.0%. Endpoint HbA1c±SE was lower for INH (7.6±0.06%) vs MET (7.8±0.07%), P=0.025. Study discontinuation was greater for MET (11%) than INH (6%), P=0.04. Pooling strata, Overall QOL (in SD units) improved similarly for INH (by 0.24± 0.09, P=0.01) and MET (0.21± 0.11, P=0.06). Overall Satisfaction (scaled 0 ϑ 100) improved substantially and similarly for INH (62±1 to 76±1, P = 0.0001) and MET (63±1 to 74±1, P=0.0001). However, endorsement for treatment increased more for INH (61±3 to 90±2) than MET (64±3 to 81±2), P=0.005. Somewhat more dissatisfaction with side effects (weight gain and hypoglycemia) was found for INH (83±1 to 77±2) vs MET (82±1 to 81±2), P=0.047. There was no change in burden or convenience. For stratum HbA1c > 9.5%, endpoint HbA1c was lower for INH (7.8±0.09%) than MET (8.3±0.12%), P=0.01, and improvement in Overall Satisfaction was 42% greater for INH (60±2 to 77±1) than MET (61±2 to 73±2), P=0.02. Conclusions: In this international study, individuals with HbA1c between 8 and 12% showed superior glycemic control and lower discontinuation with Exubera® compared to metformin, while improving satisfaction and QOL similar to metformin. For those with HbA1c > 9.5,%, superior efficacy with Exubera® and neutral quality-of-life burden translated into higher overall patient satisfaction with diabetes treatment as compared to metformin. |