T. Antonucci et al., IMPAIRED GLUCOSE-TOLERANCE IS NORMALIZED BY TREATMENT WITH THE THIAZOLIDINEDIONE TROGLITAZONE, Diabetes care, 20(2), 1997, pp. 188-193
OBJECTIVE - The primary purpose of this study was to assess the effect
s of 12 weeks of treatment with either troglitazone, an investigationa
l thiazolidinedione that acts as an insulin-action enhancer, or placeb
o in patients with impaired glucose tolerance (IGT). RESEARCH DESIGN A
ND METHODS - A total of 51 subjects with IGT between 24 and 77 years o
f age were enrolled in this multicenter, double-blind, placebo-control
led, parallel group study (troglitazone, 25 patients; placebo, 26 pati
ents). Patients were randomly assigned to receive either 400 mg trogli
tazone (every morning [QAM]) or placebo (QAM). The main outcome measur
e was the oral glucose tolerance test (OGTT) assessing glucose, insuli
n, and C-peptide levels in the fasting state and every 30 min up to 2
h after ingesting the glucose load. Fasting serum levels of HbA(1c), f
ructosamine, lipids, and blood pressure were also measured. RESULTS -
A total of 46 patients completed the study The glucose, insulin, and C
-peptide responses after a glucose load were significantly reduced at
6 and 12 weeks in the troglitazone treatment group. After 6 weeks of t
reatment, 75% (n = 18) of those taking troglitazone had improved to no
rmal glucose tolerance, whereas only 38% (n = 9) of those on placebo s
howed improvement (P = 0.008). After 12 weeks of treatment, 80% (n = 1
6) of the troglitazone treatment group had normalized their glucose to
lerance, while only 48% (n = 10) of those on placebo had converted to
normal (P = 0.016). Fasting triglyceride levels in the troglitazone tr
eatment group had decreased by 40 mg/dl (0.45 mmol/l) (P = 0.0016). Ot
her lipid measurements, blood pressure, glycosylated hemoglobin, and f
ructosamine were normal at baseline for both treatment groups and rema
ined normal throughout the study CONCLUSIONS - The glycemic response a
fter a glucose load is statistically and clinically significantly impr
oved for patients with IGT treated with troglitazone.