M. Ravnikoblak et F. Mrevlje, INSULIN VERSUS A COMBINATION OF INSULIN AND SULFONYLUREA IN THE TREATMENT OF NIDDM PATIENTS WITH SECONDARY ORAL FAILURE, Diabetes research and clinical practice, 30(1), 1995, pp. 27-35
Aim: Comparison of the effectiveness of combined therapy vs. an insuli
n regimen in NIDDM patients with secondary failure of oral hypoglycemi
c agents. Research design, patients and method;: 27 NIDDM patients wer
e randomly allocated to Group A (n = 14, insulin) and Group B (n = 13,
insulin and sulfonylurea) with crossover after 3 months. After the ne
xt 3 months a decision was made about the further treatment according
to the metabolic control. The patients were then treated for another y
ear with the more successful regimen. Metabolic control, residual beta
-cell secretory capacity, degree of peripheral insulin resistance (cla
mp) and insulin dose were followed during the whole study. Results. (m
edian, interquartile range, in brackets; , statistically significant
difference at P < 0,05): the combined therapy was better then insulin
alone in 2/3 of patients. Glycemic control was better (HbA(1c) at 3 mo
nths: Group A = 7.9(1.1)% vs. Group B = 7.0(0.5)%; HbA(1c), at 6 mont
hs: Group A = 7.4(1.5)% vs. Group B = 8.1(1.5)%. Insulin dose was lowe
r during the combined therapy in the first 3 months: Group A = 0.62(0.
18) U/kg body weight vs. Group B = 0.39(0.16) U/kg body weight. Combi
ned treatment was associated with increased C-peptide excretion both f
asting and postprandially. No significant differences in peripheral in
sulin resistance were noted between the two groups. The combined treat
ment remained successful even after one year. The two groups of patien
ts with different effective treatment did not differ significantly in
any of the observed parameters. Conclusions: the combined therapy was
more effective than insulin alone. Its favourable effect persisted aft
er treatment for a year. It seems better to start the treatment of the
oral failure with combined therapy compared with insulin first and la
ter followed by combined therapy. On the basis of the observed paramet
ers it is impossible to determine in advance which kind of treatment i
s more suitable for the individual patient.