Shoko Tsukube1, Takashi Kadowaki2, Masato Odawara3. 1. Sanofi.K.K., Tokyo Opera City Tower, 3-20-2 Nishi-shinjuku, Shinjuku-ku, Tokyo 163-1488 Japan. 2. 2Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan. 3. 3Department of Diabetology, Metabolism, and Endocrinology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023 Japan.
Abstract
AIMS AND INTRODUCTION: We aimed to explore concomitant orally administered antidiabetic agent (OAD) regimens used in basal supported oral therapy (BOT) with insulin glargine in a real-life setting, and to assess the efficacy and safety of each regimen using data from the Add-on Lantus® to Oral Hypoglycemic Agents 2 study, a 24-week observational study in Japanese type 2 diabetes patients. MATERIALS AND METHODS: Among 1629 insulin-naïve patients who had a glycosylated hemoglobin (HbA1c) value of ≥6.5 % during the previous 4 weeks and were treated with BOT during the observational period, 1227 patients who retained the same concomitant OAD regimens throughout the period were included in the analysis. RESULTS: Sulfonylurea (71.5 %), dipeptidyl peptidase-4 inhibitor (DPP-4i; 60.7 %), and biguanide (BG; 48.6 %) were commonly administered OADs in BOT. The HbA1c level decreased in patients taking BG alone (-2.76 %) and DPP-4i alone (-2.46 %). Of the three OADs, mean doses of the most frequently administered OAD changed from baseline to the final evaluation point: 2.5-2.3 mg for glimepiride, 59.1-58.7 mg for sitagliptin, and 1145.6-1168.2 mg for metformin. No significant difference in the hypoglycemia incidence rate was found between regimens (p = 0.3765), with incidence rates of 1.9 % (DPP-4i alone) to 7.0 % (other regimens) observed. CONCLUSIONS: DPP-4i plays a major role in BOT with insulin glargine in a real-life setting. The incidence of hypoglycemia did not differ significantly between BOT regimens, including DPP-4i. Insulin glargine added to DPP-4i is a potential therapeutic approach.
AIMS AND INTRODUCTION: We aimed to explore concomitant orally administered antidiabetic agent (OAD) regimens used in basal supported oral therapy (BOT) with insulin glargine in a real-life setting, and to assess the efficacy and safety of each regimen using data from the Add-on Lantus® to Oral Hypoglycemic Agents 2 study, a 24-week observational study in Japanese type 2 diabetes patients. MATERIALS AND METHODS: Among 1629 insulin-naïve patients who had a glycosylated hemoglobin (HbA1c) value of ≥6.5 % during the previous 4 weeks and were treated with BOT during the observational period, 1227 patients who retained the same concomitant OAD regimens throughout the period were included in the analysis. RESULTS: Sulfonylurea (71.5 %), dipeptidyl peptidase-4 inhibitor (DPP-4i; 60.7 %), and biguanide (BG; 48.6 %) were commonly administered OADs in BOT. The HbA1c level decreased in patients taking BG alone (-2.76 %) and DPP-4i alone (-2.46 %). Of the three OADs, mean doses of the most frequently administered OAD changed from baseline to the final evaluation point: 2.5-2.3 mg for glimepiride, 59.1-58.7 mg for sitagliptin, and 1145.6-1168.2 mg for metformin. No significant difference in the hypoglycemia incidence rate was found between regimens (p = 0.3765), with incidence rates of 1.9 % (DPP-4i alone) to 7.0 % (other regimens) observed. CONCLUSIONS: DPP-4i plays a major role in BOT with insulin glargine in a real-life setting. The incidence of hypoglycemia did not differ significantly between BOT regimens, including DPP-4i. Insulin glargine added to DPP-4i is a potential therapeutic approach.
Authors: T Vilsbøll; J Rosenstock; H Yki-Järvinen; W T Cefalu; Y Chen; E Luo; B Musser; P J Andryuk; Y Ling; K D Kaufman; J M Amatruda; S S Engel; L Katz Journal: Diabetes Obes Metab Date: 2010-02 Impact factor: 6.577
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