Mn. Feinglos et al., COMBINATION INSULIN AND SULFONYLUREA THERAPY IN INSULIN-REQUIRING TYPE-2 DIABETES-MELLITUS, Diabetes research and clinical practice, 39(3), 1998, pp. 193-199
Purpose: To determine the effect(s) on glucose control, insulin dose,
and circulating insulin levels of the addition of a sulfonylurea (glip
izide) to the treatment regimen of patients with insulin-requiring typ
e 2 diabetes mellitus. Patients and Methods: Thirty seven patients wit
h type 2 diabetes mellitus taking insulin for at least 1 year prior to
study and treated with greater than or equal to 40 U of insulin per d
ay were recruited for a randomized, double-blind, placebo-controlled,
crossover trial. Patients were treated with 3 months of insulin + plac
ebo (I + P) and 3 months of insulin + glipizide (I + G) with an interm
ediate 1 month washout period using insulin therapy alone. Adjustments
were made initially to the maximum dose of glipizide (40 mg/day), fol
lowed by insulin dose adjustments. Twenty-nine of the 37 patients demo
nstrated a significant C-peptide response to Ensure(R) and were select
ed for analysis. Results: The Fasting plasma glucose in the I + G arm
was 6.8 (121.8 mg/dl) vs. 8.7 mmol/L (156.0 mg/dl) in the I + P arm, P
< 0.001. Mean plasma glucose over 24 hours was 9.8 (176.9 mg/dl) for
I + G vs. 11.3 mmol/L (203.8 mg/dl) for I + P, P < 0.001. Glycated hem
oglobin was significantly different (9.8 I + G vs. 11.4% I + P, P < 0.
008). The total daily insulin dose required was significantly lower wi
th I + G (69.1 vs. 87.3 U, P < 0.0005). However, there were no signifi
cant differences in free insulin levels. Conclusion: The addition of a
sulfonylurea (glipizide) to insulin therapy in patients with insulin-
requiring type 2 diabetes mellitus taking large doses of insulin resul
ts in a rapid and substantial improvement in glucose control despite a
significant reduction in insulin dose. Therefore, this form of combin
ation therapy should be considered for patients with the above charact
eristics whose diet and exercise programs are correct but whose respon
se to insulin therapy is inadequate. (C) 1998 Elsevier Science Ireland
Ltd. All rights reserved.