Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus

A placebo-controlled, double-blind, multicentre study

Gabriele Riccardi, R. Giacco, M. Parillo, S. Turco, A. A. Rivellese, M. R. Ventura, S. Contadini, G. Marra, M. Monteduro, F. Santeusanio, P. Brunetti, M. C. Librenti, A. E. Pontiroli, P. Vedani, G. Pozza, L. Bergamini, C. Bianchi

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Aims: The aim of the study was to evaluate the efficacy and safety of acarbose in patients with Type 1 diabetes mellitus (DM). Methods: A multicentre double-blind, randomized, placebo-controlled study was performed. After a 6-week run-in, 121 patients were randomized to acarbose or placebo and to high- or low-fibre diet for 24 weeks. Acarbose dose was 50 mg t.d.s. for the first 2 weeks and 100 mg t.d.s. for the subsequent weeks. Results: At the end of 24 weeks of treatment the intention to treat analysis showed that acarbose compared with placebo decreased 2 h postprandial plasma glucose levels (12.23 ± 0.83 vs. 14.93 ± 0.87 mmol/l; F= 6.1, P<0.02) (least square means ± SEM). No significant effect of acarbose was recorded on HbA(1c) or on the number of hypoglycaemic episodes. The effect of acarbose on blood glucose control was not influenced by the amount of carbohydrate and/or fibre intake. The incidence of adverse events were 75% and 39% in acarbose and placebo groups, respectively; they were mild and confined to the gastrointestinal tract. Conclusions: The use of acarbose in combination with insulin reduces postorandial plasma glucose levels in Type 1 diabetic patients who are not satisfactorily controlled with insulin alone but without significant effect on HbA(1c).

Original languageEnglish
Pages (from-to)228-232
Number of pages5
JournalDiabetic Medicine
Volume16
Issue number3
DOIs
Publication statusPublished - 1999

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Acarbose
Type 1 Diabetes Mellitus
Double-Blind Method
Multicenter Studies
Placebos
Safety
Therapeutics
Insulin
Glucose
Intention to Treat Analysis
Least-Squares Analysis
Hypoglycemic Agents
Blood Glucose
Gastrointestinal Tract
Carbohydrates
Diet
Incidence

Keywords

  • Acarbose
  • Efficacy
  • Safety
  • Type 1 diabetes

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus : A placebo-controlled, double-blind, multicentre study. / Riccardi, Gabriele; Giacco, R.; Parillo, M.; Turco, S.; Rivellese, A. A.; Ventura, M. R.; Contadini, S.; Marra, G.; Monteduro, M.; Santeusanio, F.; Brunetti, P.; Librenti, M. C.; Pontiroli, A. E.; Vedani, P.; Pozza, G.; Bergamini, L.; Bianchi, C.

In: Diabetic Medicine, Vol. 16, No. 3, 1999, p. 228-232.

Research output: Contribution to journalArticle

Riccardi, G, Giacco, R, Parillo, M, Turco, S, Rivellese, AA, Ventura, MR, Contadini, S, Marra, G, Monteduro, M, Santeusanio, F, Brunetti, P, Librenti, MC, Pontiroli, AE, Vedani, P, Pozza, G, Bergamini, L & Bianchi, C 1999, 'Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus: A placebo-controlled, double-blind, multicentre study', Diabetic Medicine, vol. 16, no. 3, pp. 228-232. https://doi.org/10.1046/j.1464-5491.1999.00047.x
Riccardi, Gabriele ; Giacco, R. ; Parillo, M. ; Turco, S. ; Rivellese, A. A. ; Ventura, M. R. ; Contadini, S. ; Marra, G. ; Monteduro, M. ; Santeusanio, F. ; Brunetti, P. ; Librenti, M. C. ; Pontiroli, A. E. ; Vedani, P. ; Pozza, G. ; Bergamini, L. ; Bianchi, C. / Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus : A placebo-controlled, double-blind, multicentre study. In: Diabetic Medicine. 1999 ; Vol. 16, No. 3. pp. 228-232.
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AU - Rivellese, A. A.

AU - Ventura, M. R.

AU - Contadini, S.

AU - Marra, G.

AU - Monteduro, M.

AU - Santeusanio, F.

AU - Brunetti, P.

AU - Librenti, M. C.

AU - Pontiroli, A. E.

AU - Vedani, P.

AU - Pozza, G.

AU - Bergamini, L.

AU - Bianchi, C.

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N2 - Aims: The aim of the study was to evaluate the efficacy and safety of acarbose in patients with Type 1 diabetes mellitus (DM). Methods: A multicentre double-blind, randomized, placebo-controlled study was performed. After a 6-week run-in, 121 patients were randomized to acarbose or placebo and to high- or low-fibre diet for 24 weeks. Acarbose dose was 50 mg t.d.s. for the first 2 weeks and 100 mg t.d.s. for the subsequent weeks. Results: At the end of 24 weeks of treatment the intention to treat analysis showed that acarbose compared with placebo decreased 2 h postprandial plasma glucose levels (12.23 ± 0.83 vs. 14.93 ± 0.87 mmol/l; F= 6.1, P<0.02) (least square means ± SEM). No significant effect of acarbose was recorded on HbA(1c) or on the number of hypoglycaemic episodes. The effect of acarbose on blood glucose control was not influenced by the amount of carbohydrate and/or fibre intake. The incidence of adverse events were 75% and 39% in acarbose and placebo groups, respectively; they were mild and confined to the gastrointestinal tract. Conclusions: The use of acarbose in combination with insulin reduces postorandial plasma glucose levels in Type 1 diabetic patients who are not satisfactorily controlled with insulin alone but without significant effect on HbA(1c).

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