Effect of miglitol (BAY m-1099) on fasting blood glucose in type 2 diabetes mellitus.

BACKGROUND: In type 2 diabetes mellitus, fasting blood glucose values are increased due to increased glycogenolysis and gluconeogenesis. As miglitol (BAY m-1099), an absorbable alpha-glucosidase inhibitor, can inhibit glycogenolysis, we investigated whether 200 mg miglitol ingested at bedtime could decrease fasting blood glucose values. METHODS: Twelve type 2 diabetic patients participated in a double-blind, randomised, placebo-controlled, cross-over study. The study duration was 6 weeks: 2 weeks run-in, 2 test periods of 1 week with 2 weeks of wash-out in between. During run-in and wash-out periods placebo tablets were used. Fasting blood glucose (FBG), insulin (FIRI), C-peptide (FCP), glucagon (FG), pyruvate and alanine were measured at the start of the study, at the end of the run-in and wash-out periods, and at the 6th and 7th day of each test period. RESULTS: Both during miglitol and placebo no effects on FBG (12.2 +/- 2.5 vs. 12.2 +/- 2.5 mmol/l), FIRI (80 +/- 34 vs. 82 +/- 35 pmol/l), FCP (1110 +/- 303 vs. 1043 +/- 304 pmol/l), FG (20 +/- 13 vs. 20 +/- 10 pmol/l), pyruvate (101 +/- 28 vs. 112 +/- 30 mumol/l) or alanine (440 +/- 87 vs. 465 +/- 133 mumol/l) were observed. CONCLUSIONS: Miglitol 200 mg taken at bedtime for 1 week has no influence on hepatic glucose production.

Efficacy and tolerability of single-dose versus six-day treatment of candidal vulvovaginitis with vaginal tablets of clotrimazole.

One hundred ninety-nine female patients with candidal vulvovaginitis were included in an open, randomized, mycologically controlled study carried out at three Dutch gynecologic clinics to determine the efficacy and tolerability of a single vaginal tablet containing 500 mg clotrimazole in comparison with a 6-day treatment with vaginal tablets containing 100 mg clotrimazole. Both groups were comparable in age, body weight, and duration and severity of the infection, and in both groups the percentage of patients who were also treated for vulvitis with a 1% clotrimazole cream and the percentage of the male partners who were treated were equal. Four weeks after therapy, 84 of the 102 patients (82.4%) treated with one dose of 500 mg clotrimazole were cured and 82 of the 97 patients (84.5%) of the 6-day treatment group were cured. The clinical symptoms improved parallel to the improvement of mycologic findings. Both the vaginal tablets containing 500 mg and those containing 100 mg clotrimazole were well tolerated by the patients. After 1 week the results of the single-dose treatment with 500 mg clotrimazole were slightly better than those of the 6-day treatment with vaginal tablets of 100 mg clotrimazole. After 4 weeks the results were reversed, but it should be considered that this could be due to reinfection of the patients.

One-dose therapy of Candida vaginitis. I. Results of an open multicentre trial.

90 female patients suffering from Candida vaginitis were included in an open, mycologically controlled study, carried out at three gynaecological clinics, to investigate the efficacy and tolerance of one single vaginal tablet containing 500 mg clotrimazole (Canesten 1). In 40% of the patients the infection was considered to be mild and in 60% severe. In order to confirm the diagnosis and to evaluate the therapeutic effect (before application and 1 as well as 4 weeks after therapy), the following criteria were considered: (1) identification of Candida species on direct microscopic examination (wet film) and also by culture on a Nickerson medium, and (2) influence on the clinical symptoms, such as itching, burning, pathological changes of the vaginal mucosa, thrush. The principle criterion was the cultural mycological finding. In 79 patients (88%) the culture was negative 1 week after therapy and in 81 (90%) 4 weeks after therapy; 9 patients (10%) were treatment failures with positive cultural findings at the last control. The clinical symptoms improved parallel to the mycological findings. At the controls they had disappeared in the majority (up to 90%) of the affected patients. The favourable impression achieved at consideration of the cultural findings could be confirmed at the overall assessment by the clinicians: 88% of the patients were cured 1 week after application and 90% 4 weeks after application. By means of different criteria the state of disease did not have any influence on the therapeutic success. The 500-mg clotrimazole vaginal tablet was very well tolerated by all patients.