Efficacy of adding once-daily insulin glulisine in Japanese type 2 diabetes
patients treated with insulin glargine and sitagliptin.
Author(s): Takahara M(1), Shiraiwa T, Katakami N, Matsuoka TA, Shimomura I.
Affiliation(s): Author information:
(1)1 Department of Metabolic Medicine, Osaka University Graduate School of
Medicine , Suita, Osaka, Japan .
Publication date & source: 2014, Diabetes Technol Ther. , 16(10):633-9
BACKGROUND: Glucose fluctuation often remains to be corrected under
basal-supported oral therapy. We investigated the efficacy of adding once-daily
rapid-acting insulin in Japanese diabetes patients treated with basal-supported
oral therapy.
SUBJECTS AND METHODS: In this 8-week, parallel-group, randomized, open-label
trial, 62 Japanese adults with type 2 diabetes treated with insulin glargine and
50 mg of sitagliptin were randomized into the following two arms: the
single-bolus group, in which once-daily insulin glulisine was initiated at a main
meal at a fifth (i.e., 20%) the dose of insulin glargine, and the control group,
in which the dose of sitagliptin was maximized to 100 mg. The primary end point
was the change of glycemic fluctuation assessed with the M-value.
RESULTS: Baseline hemoglobin A1c levels, mean blood glucose profiles, and M-value
were 7.2 ± 0.6%, 9.3 ± 1.7 mmol/L, and 21 ± 13 units, respectively. At the end of
the study, the single-bolus group had a greater reduction of M-value than the
control group (P=0.02); the difference was 6.5 units (95% confidence interval,
1.1-11.9 units). The single-bolus group also had a greater reduction of mean
blood glucose levels (P=0.01). There were no significant differences in the
incidence of hypoglycemia or the weight change between the two groups (P>0.05).
CONCLUSIONS: Adding once-daily insulin glulisine was more effective in
controlling the glycemic fluctuation in Japanese type 2 diabetes patients treated
with insulin glargine together with sitagliptin.
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