Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus: a placebo-controlled, double-blind, multicentre study.
OBJECTIVE
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 HbA1c 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 postprandial plasma glucose levels in Type 1 diabetic patients who are not satisfactorily controlled with insulin alone but without significant effect on HbA1c.
Riccardi
G
G
Department of Clinical and Experimental Medicine, Medical School, University of Naples Federico II, Italy.
Giacco
R
R
Parillo
M
M
Turco
S
S
Rivellese
A A
AA
Ventura
M R
MR
Contadini
S
S
Marra
G
G
Monteduro
M
M
Santeusanio
F
F
Brunetti
P
P
Librenti
M C
MC
Pontiroli
A E
AE
Vedani
P
P
Pozza
G
G
Bergamini
L
L
Bianchi
C
C
D020909:Acarbose; D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004040:Dietary Carbohydrates / Q000494:pharmacology; D004043:Dietary Fiber / Q000494:pharmacology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014312:Trisaccharides / Q000009:adverse effects / Q000627:therapeutic use*
D001786:Blood Glucose; D004040:Dietary Carbohydrates; D004043:Dietary Fiber; D014312:Trisaccharides; D020909:Acarbose