[Changes in weight and diabetes compensation (HbA1c) in patients with diabetes mellitus type 2 after adding exenatide (Byetta) to the current treatment in 28 diabetology departments in the Czech Republic -  BIBYII study (observations lasting 24 months)]. / Zmeny hmotnosti a kompenzace diabetu (HbA1c) u nemocných s diabetes mellitus 2. typu po pridání exenatidu (Byetta) ke stávající lécbe ve 28 diabetologických ambulancích v CR -  studie BIBYII (sledování 24 mesícu).

UNLABELLED: BIBYII STUDY OBJECTIVE: To obtain experience with longterm (24 months) exenatide treatment (Byetta) in patients with diabetes mellitus type 2 from a common clinical practice of diabetology departments in the Czech Republic. 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: From the original population of 465 patients, who underwent a minimum of three months Byetta treatment, 169 patients (36.6%) remained during the second prolonged observation after 18 months, and 76 patients completed 24 months of uninterrupted Byetta treatment. The following basic information about the patients was collected: year of birth, sex, age when diabetes mellitus (DM) manifested, height, maximum weight before diabetes and when DM manifested. The study recorded the following values in three- month intervals: weight, waistline, glycated haemoglobin (HbA1c), and DM treatment. The population of the prolonged observation comprised 50.3% women and 49.7 % men, and the average age at the time of DM2 manifestation was 48.0 (20- 73 years). RESULTS: At the beginning of Byetta treatment, the average maximum BMI in the subpopulation observed for 24 months was 38.44; after 3, 6, 9, 12 and 24 months the following levels were measured, respectively: 36.79, 36.22, 35.91, 35.57 and 35.58. The original HbA1c level of 7.44% at the beginning of Byetta treatment decreased after 3, 6, 9, 12 and 24 months to 6.33, 5.98, 5.83, 5.86 and 5.93%. CONCLUSION: Adding Byetta to the currently applied treatment of obese patients with diabetes mellitus type 2 over a period of 24 months has led to an improvement in HbA1c level by 1.51%, and BMI level was reduced by 2.37 after two years of Byetta treatment.

[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)]. / Zmeny hmotnosti a kompenzace diabetu (HbA(1c)) u nemocných s diabetes mellitus 2. tpu po pridání exenatidu (Byetta) ke stávající lécbe ve 28 diabetologických ambulancích v CR--studie BIBY-I (sledováni 3-12 mesícu).

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.

Low risk of severe hypoglycaemia in patients with type 2 diabetes mellitus starting insulin therapy with premixed insulin analogues BID in outpatient settings.

AIMS: The choice of insulin at initiation in type 2 diabetes remains controversial. The aim of this study was to assess the occurrence of self-reported severe hypoglycaemia associated with premixed insulin analogues in routine clinical care. METHODS: A 12-month, prospective, observational, multicentre study in patients starting a commonly prescribed premixed insulin analogue (either insulin lispro 25/75 or biphasic insulin aspart 30/70, twice daily) after suboptimal glycaemic control on oral antidiabetic agents. Treatment decisions were made solely in the course of usual practice. RESULTS: Study follow-up was completed by 991 (85.5%) of the 1150 patients enrolled. At baseline, mean (SD) age was 57.9 (10.1) years; mean diabetes duration was 9.2 (5.9) years; mean haemoglobin A(1c) (HbA(1c)) was 9.9 (1.8) % and the rate of severe hypoglycaemia was 0.03 episode/patient-year. At 12 months, the rate of severe hypoglycaemia was 0.04 episode/patient-year (95% CI 0.023, 0.055 episode/patient-year) and mean insulin dose was 41.5 (19.4) units. Changes from baseline to 12 months for mean fasting plasma glucose and HbA(1c) were -5.1 mmol/l and -2.5%, respectively. CONCLUSIONS: After initiation of premixed insulin analogues in patients with type 2 diabetes in real-world settings, the incidence of severe hypoglycaemia was lower than expected from previously reported studies.