[Changes in weight and diabetes compensation (HbA(1c)) in patients with diabetes mellitus type 2 after adding exenatide (Byetta) to the current treatment in 28 diabetology departments in the Czech Republic - BIBY-I study (observations lasting 3 to 12 months)].

UNLABELLED

BIBY STUDY OBJECTIVE: To obtain experience with exenatide treatment (Byetta) in patients with diabetes mellitus type 2 in a common clinical practice ofdiabetology departments. TYPE OF OBSERVATION: Observational study conducted by a randomly selected group of outpatient medical practitioners from 28 diabetology departments in the Czech Republic. OBSERVED AND ASSESSED POPULATION: 465 patients underwent at least three months of Byetta treatment; 347 persons (74.6% ofthe research population) stayed forthe extended observation of 6-12 months. Apart from the basic identification data (year of birth, sex, age when diabetes mellitus manifested, height, maximum patient weight before diabetes and when diabetes mellitus manifested), the following information was recorded in three-month intervals: weight, waistline, glycated haemoglobin (HbA(1c)), and diabetes mellitus treatment The population included 50.3% women and 49.7% men, and the average age at the time of diabetes manifestation was 48 (20-73 years). The period between the diabetes manifestation and the start of exenatide treatment was 8.3 years on average.

RESULTS

The average maximum BMI value before the detection of diabetes was 39.05 (+/- 6.73); at the time of the diabetes manifestation 37.88 (+/- 6.40); and at the start of Byetta treatment 39.01 (+/- 6.22). The BMI after three, six, and 12 months of treatment was as follows: 37.86 (+/- 6.12), 37.18 (+/- 6.0), and 36.60 (+/- 6.21); it decreased by > or = 0.5 in 83.3% patients who were under observation for 12 months. HbA(1c) value decreased in the first three months from 7.39% (+/- 1.57) to 6.41% (+/- 1.34), p < 0.0001. In the period of three-six months, the value decreased to 6.22% (+/- 1.34), and after 12 months, HbA(1c) was at 6.04 (+/- 1.20). An improvement in HbA(1c) value of 0.5-2.0% occurred after the first year in 49% of our research population. The waistline was measured on a regular basis in only 267 patients (58.9%). The average initial value of 120.7 cm was reduced within three months of the treatment to 118.3 cm, and within six and 12 months to 117.3 and 112.6 cm respectively.

CONCLUSION

Adding Byetta to the currently applied treatment of obese patients with diabetes mellitus type 2 led, in 66.8% of the population, to a statistically significant reduction in HbA(1c) levels in the first three-six months of the treatment; after 12 months of treatment, 25% of the population was still showing an improvement in HbA(1c) of > 2.0%. Of observed patients, 74.4% significantly reduced their BMI (by > 0.5) during the first three months; 39.6% of patients reduced their BMI in the period of three-six months.