Predictors for achieving target glycemic control in Japanese patients with type 2 diabetes after initiation of basal supported oral therapy using insulin glargine: sub-analysis of the ALOHA2 study, drug use surveillance in Japan
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We aimed to identify diabetes-related factors associated with achieving HbA1c <7.0 % after the initiation of basal supported oral therapy (BOT) in insulin-naïve type 2 diabetes patients with an HbA1c value of ≥6.5 % during the previous 4 weeks, using data from Add-on Lantus® to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week observational study on Japanese type 2 diabetes patients.
Patients were categorized into two groups: HbA1c <7.0 % at the final evaluation point (at 24 weeks or the last visit) as HbA1c-target-achieved; HbA1c ≥7.0 % as target-not-achieved. Associations between baseline factors and HbA1c <7.0 % achievement were explored using logistic regression.
Of the 1520 patients in the study, 400 patients (26.3 %) achieved HbA1c <7.0 %. Patients with diabetes duration of <1 year and between ≥1 and <2 years [odds ratio (OR): 5.27, 95 % confidence interval (CI): 1.13–24.51; OR: 3.77, 95 % CI 1.19–11.93, respectively], those on one pre-study orally administered antidiabetic agent (OAD) (OR: 2.42, 95 % CI 1.12–5.22), and those with absence of diabetic neuropathy (OR: 2.54, 95 % CI 1.12–5.76) were more likely to achieve HbA1c <7.0 % than those with duration of ≤15 years, ≥4 pre-study OADs, and neuropathy, respectively. Achievement of HbA1c <7.0 % among patients increased by approximately 20 % for each 1 % decrease in HbA1c level at baseline.
Shorter diabetes duration, pre-study regimen of one OAD, absence of neuropathy, and lower HbA1c level at baseline were associated with achievement of HbA1c <7.0 %, suggesting that earlier initiation of BOT leads to good HbA1c control in insulin-naïve Japanese type 2 diabetes patients, consistent with our early ALOHA study.
KeywordsType 2 diabetes Basal supported oral therapy Insulin glargine Real-life observational study
The authors are grateful to all physicians at the hospitals and clinics participating in the ALOHA2 study. Statistical analysis was performed by EPS Corp., and editorial support was provided by Clinical Study Support, Inc., both under contract with Sanofi K.K. This study was conducted and sponsored by Sanofi K.K.
Sanofi K.K. had responsibility for the study design, statistical analysis plan, and drafting and approval of the manuscript. YI and ST drafted the manuscript. TK and MO made significant suggestions regarding analysis and interpretation of the data, and reviewed and revised the draft manuscript. All authors have reviewed and approved the final version of this manuscript.
Compliance with ethical standards
This study was conducted as a special drug use surveillance and complied with the Pharmaceutical Affairs Law enacted by the Japanese Health Authority and the ministerial ordinance, “Good Post-Marketing Study Practice (GPSP)”, and was conducted after a contract was signed with each medical institution participating in the survey.
Conflict of interest
YI and ST are employees of Sanofi K.K., Tokyo, Japan. Insulin glargine is marketed by Sanofi K.K. under the name Lantus®. TK has served on advisory panels for Boehringer Ingelheim, Daiichi-Sankyo, Novo Nordisk, Taisho, Takeda and Tanabe-Mitsubishi, and has served as a consultant for Boehringer Ingelheim and MSD (Merck), and has received research support from AstraZeneca, Chugai, Daiichi-Sankyo, MSD, Ono, Sanofi, Takeda and Tanabe-Mitsubishi, and has served on speakers’ bureaus for Astellas, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Dainippon Sumitomo, Eli Lilly, Kowa, Kyowahakko Kirin, MSD, Novartis, Ono, Sanofi, Sanwa, Taisho, Takeda and Tanabe-Mitsubishi. MO has served on advisory panels for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi and Taisho, has received research support from Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Dainippon Sumitomo, Eli Lilly, Kowa, Kyowa Hakko Kirin, MSD, Novartis, Ono, Sanofi, Taisho, Takeda and Tanabe-Mitsubishi, and has served on speakers’ bureaus for Astellas, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Dainippon Sumitomo, Eli Lilly, Kowa, Kyowahakko Kirin, MSD, Novartis, Ono, Sanofi, Taisho, Takeda and Tanabe-Mitsubishi.
Informed consent or substituted consent was obtained from all patients included in the ALOHA2 study.
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