MULTICENTRIC CLINICAL TRIAL TO ASSESS EFFICACY AND TOLERABILITY OF ACARBOSE (BAY g 5421) IN COMPARISON TO GLIBENCLAMIDE AND PLACEBO

I. Kovacevic1, V. Profozic1, Z. Skrabalo1, T. Cabrijan2, V. Zjacic-Rotkvic2, V. Goldoni2, Lj. Jovic-Paskvalin3, Z. Crncevic-Orlic4, M. Koselj5, Z. Metelko1

1Vuk Vrhovac Institute, University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Dugi dol 4a, 10000 Zagreb, Croatia

2Center for Endocrinology, Diabetes and Metabolic Diseases, Sestre milosrdnice University Hospital, Vinogradska c. 29, 10000 Zagreb, Croatia

3Regional Center for Diabetes, 51000 Rijeka, Croatia

4Department of Endocrinology, Rijeka University Hospital, 51000 Rijeka, Croatia

5Center for Diabetes, University Hospital, Ljubljana, Slovenia

Professional Paper

Received: April 18, 1997

Key words: non-insulin dependent diabetes mellitus, oral therapy, acarbose

SUMMARY

The efficacy and tolerability of acarbose were assessed in comparison to glibenclamide (single-blind) and placebo (double-blind) in 102 non-insulin dependent diabetics with poorly regulated glycemia by basic principles of treatment alone, BMI<35. HbA1c values of the three treatment groups (acarbose, glibenclamide and placebo) were 8.3±0.7%, 9.0±1.0% and 8.3±1.0% at the beginning, and 7.6±0.9%, 7.4±1.2% and 8.5±1.7% at the end of the study, respectively. At the end of the study, differences were significant between acarbose and placebo (p<0.0008), and glibenclamide and placebo (p<0.0001). The relative blood glucose postprandial increase was 5.3±1.9, 5.6±2.4 and 5.6±1.8 mmol/l at the beginning, and 2.5±1.5, 4.5±2.5 and 4.7±2.4 mmol/l at the end of the study. Differences were statistically significant between acarbose and placebo (p<0.01). The relative postprandial insulin increase was 2.18±1.51, 2.27±1.54 and 2.22±1.63 mU/l at the beginning, and 1.80±1.85, 2.93±1.80 and 2.89±1.85 mU/l at the end of the study. After 24 weeks, differences were statistically significant between acarbose and glibenclamide (p<0.02), and acarbose and placebo (p<0.03). The pronounced glucoregulatory effect of non-betacytotropic properties might be of great interest in the treatment of NIDDM patients.


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