| Abstrakt: |
Objective: To evaluate whether exenatide administered before breakfast and dinner (BD) or before lunch and dinner (LD) provided similar glycemic control in Latin American patients with type 2 diabetes mellitus (T2DM) who consume a small breakfast.Methods: In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-μg exenatide for 4 weeks, then 10-μg exenatide for 8 weeks). Treatment assignment was determined by a computer-generated random sequence using an interactive response system. Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast. The primary endpoint was HbA1c change from baseline to endpoint. Secondary endpoints included fasting serum glucose (FSG) level, 7-point SMBG profile, and safety. Clinicaltrials.gov Identifier: NCT00359879.Results: 377 participants (55% female, age 54 ± 10 years, weight 82 ± 15 kg, BMI 31 ± 4 kg/m2, HbA1c 8.4 ± 0.9%; mean ± SD) from Brazil and Mexico were randomized to study treatment. HbA1c reduction with exenatide administration before BD was non-inferior to administration before LD (mean difference between (LD–BD) treatments: 0.14%; 95% CI −0.04 to 0.32%, p=0.120). Both treatments resulted in statistically significant HbA1c reductions at endpoint (BD −1.2% and LD −1.1%, respectively, p<0.001). In Brazil, the non-inferiority criteria were met for HbA1c reduction between treatment arms (−0.12%; CI −0.37 to 0.13%, p=0.344), whereas in Mexico, there was a difference favoring exenatide administration before BD (0.41%; CI 0.16 to 0.66%, p=0.002). At endpoint, there were no statistical significant differences between the BD and LD arms in mean change in FSG (0.50 mmol/L; CI −0.02 to 1.02 mmol/L, p=0.058) and daily mean change in SMBG (0.19 mmol/L; CI −0.17 to 0.54 mmol/L, p=0.295). The rates of symptomatic hypoglycemia (5.2 events/patient-year vs. 6.1 events/patient-year) and nausea (23% vs. 25%), were similar between the BD and LD arms, respectively. A limitation of the study design was that caloric intake of patients and meal times were not monitored.Conclusions: In T2DM patients who consume a small breakfast, exenatide administration before breakfast or lunch resulted in significant improvement in glycemic control. [ABSTRACT FROM AUTHOR] |
