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. 2015 Oct 5;7(2):188-198.
doi: 10.1007/s13340-015-0236-9. eCollection 2016 Jun.

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

Yukio Ikeda  1 , Shoko Tsukube  1 , Takashi Kadowaki  2 , Masato Odawara  3
Affiliations

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

Yukio Ikeda et al. Diabetol Int. .

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Basal supported oral therapy; Insulin glargine; Real-life observational study; Type 2 diabetes.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Patient disposition. a Patients who had ever been administered insulin glargine. b Patients who had not been treated with insulin previously and were treated with BOT throughout the observation period. CRF case report form, HbA1c glycosylated hemoglobin, OAD orally administered antidiabetic agent
Fig. 2
Fig. 2
Percentages of target-achieved (HbA1c <7.0 %) and target-not-achieved (HbA1c ≥7.0 %) patients by duration of diabetes at baseline. yr year, yrs years, n = 1193
Fig. 3
Fig. 3
Percentages of target-achieved (HbA1c <7.0 %) and target-not-achieved (HbA1c ≥7.0 %) patients a and diabetes duration b by HbA1c at baseline. HbA1c glycosylated hemoglobin. a, b HbA1c levels recorded as Japan Diabetes Society (JDS) values and International Federation of Clinical Chemistry (IFCC) values were converted into the National Glycohemoglobin Standardization Program (NGSP) values utilizing the following formula: NGSP (%) = 1.02 × JDS (%) + 0.25 %; or NGSP (%) = 1.02 × [IFCC (%) − 0.4 %] + 0.25 % [19]. a n = 1520, b the converted NGSP values were not rounded up; therefore, HbA1c levels close to 6.5 % in four patients were categorized in the HbA1c <6.5 % group, although their HbA1c levels met the inclusion criteria, n = 1629
Fig. 4
Fig. 4
Percentages of target-achieved (HbA1c <7.0 %) and target-not-achieved (HbA1c ≥7.0 %) patients a and change in HbA1c between baseline and final evaluation point, and b by number of pre-study OADs. OAD orally administered antidiabetic agent. (a, b) n = 1411
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