[The alpha-glucosidase inhibitor miglitol for the treatment of type 2 diabetes mellitus in the doctor's office].
METHODS
An observational study was carried out according to and 67 (6) AMG from october 1999 until august 2000. 2654 patients with diabetes mellitus type 2 were treated by 766 physicians for 3 months with alpha-glucosidase inhibitor miglitol. The aim of the study "DiaLife" was to obtain data regarding the effectiveness and safety of miglitol in the daily practice. Pre- and postprandial glucose levels, HbA1c, triglycerides, urin glucose, microalbuminuria and body weight were used as parameters of effectiveness. Also an increasing treatment scheme was used. Side effects were documented by the care providing physicians and evaluated by the global tolerability analysis.


RESULTS
Males and females showed a balanced distribution. The average age was 62 years and the average duration of diabetes was 5 years. Concomitant diseases were described for 82% of patients: 62% of patients suffered from hypertension, 43% from hyperlipidemia and 22% from coronary heart disease. 64% of patients were already on treatment for diabetes. The mostly prescribed drugs were sulfonylureas and biguanides. Miglitol was gradually increased (first week 1 x 50 mg daily, second week 2 x 50 mg daily, until the third week 3 x 50 mg daily) and the final dosages were 3 x 50 mg or 3 x 100 mg miglitol daily. HbA1c, pre- and postprandial glucose levels were strongly reduced. The HbA1c decreased from 8.4% to 7,1%. Pre- and postprandial glucose levels were reduced minus 46 mg/dl and minus 59 mg/dl. The average decrease of body weight was 1,9 kg; the effect was augmented in individuals with higher BMI. Adverse effects were reported in 47 patients and occured mainly in the GI tract. There were no problems in the combination of miglitol with other pharmacological substance groups.


CONCLUSIONS
The alpha-glucosidase inhibitor miglitol is an efficient and safe drug for the treatment of diabetes mellitus type 2. It is an ideal tool for mono- and combination therapy. It reduces remarkably the body weight. 90% of physicians judged miglitol's efficiency and safety as "very good" or "good".
Fehmann
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D017485:1-Deoxynojirimycin / Q000031:analogs & derivatives; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005944:Glucosamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis; D065089:Glycoside Hydrolase Inhibitors; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D050112:Imino Pyranoses; D008297:Male; D008875:Middle Aged; D012449:Safety; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
D017485:1-Deoxynojirimycin; D001786:Blood Glucose; D005944:Glucosamine; D006442:Glycated Hemoglobin; D065089:Glycoside Hydrolase Inhibitors; D007004:Hypoglycemic Agents; D050112:Imino Pyranoses; D014280:Triglycerides; C045621:miglitol