A prospective study to optimize insulin treatment by switching to insulin glargine in type 2 diabetic patients previously uncontrolled on premixed insulin: the optimization study

Abstract

Objective:

To evaluate the efficacy, safety and treatment satisfaction of insulin glargine plus oral antidiabetic drugs (OADs) in Chinese individuals with Type 2 diabetes inadequately controlled with premixed insulin plus OADs.

Methods:

In this open-label, single-arm, 16-week, phase IV study, 313 subjects with Type 2 diabetes inadequately controlled with premixed insulin plus OADs were switched to insulin glargine plus OADs. Changes in glycaemic control, incidence of hypoglycaemia and treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) were evaluated.

Results:

Switching to insulin glargine was associated with significant reductions in levels of glycosylated haemoglobin (HbA_1c; 8.4 ± 0.6 to 7.9 ± 1.0%; p < 0.001) and fasting plasma glucose (FPG; 9.50 ± 2.10 to 6.58 ± 2.07 mmol/L; p < 0.001). A total of 32.9% of subjects experienced hypoglycaemia, including two cases of severe hypoglycaemia. Treatment satisfaction was improved with insulin glargine (DTSQ 8-item scores, all p < 0.001). Logistic regression analysis showed a significant association between baseline HbA_1c, disease duration, endpoint FPG and HbA_1c < 7%.

Conclusion:

This single-arm study suggested that switching to insulin glargine plus OADs significantly improved glycaemic control, with a low incidence of hypoglycaemia, in patients with Type 2 diabetes uncontrolled on premixed insulin plus OADs. Switching to insulin glargine was also associated with better patient treatment satisfaction compared with previous treatment. The main limitations to this study are the open-label design and the lack of a control arm.

Key words::

• Basal insulin analogues
• Glycosylated haemoglobin (HbA_1c)
• Insulin glargine
• Premixed insulin
• Treatment satisfaction
• Type 2 diabetes

Transparency

Declaration of funding

This study was funded by sanofi-aventis.

Declaration of financial/other interest

The authors have disclosed that they received sponsorship from sanofi-aventis to conduct this study. CMRO peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors thank Zheng Gu, Shuhua Shang, Bo Mou, Sam Zhong and May Dong for manuscript preparation support. Editorial support for this article was provided by Huw Jones PhD of Medicus International and was funded by sanofi-aventis.

The authors thank the staff at all participating hospitals and especially the following investigators of the OPTIMIZATION study group: Xiaohui Guo (Peking University First Hospital), Dajin Zou (Changhai Hospital of Shanghai, Second Military Medical University), Wei Liu (Renji Hospital, Shanghai Jiao Tong University School of Medicine), Yongde Peng (Shanghai First People’s Hospital), Dalong Zhu (Nanjing Drum Tower Hospital), Bing Chen (Xinan Hospital, Third Military Medical University), Qiuhe Ji (Xijing Hospital, Fourth Military Medical University), Longyi Zeng (The Third Affiliated Hospital of Sun Yat-Sen University), Zhiguang Zhou (The Second Xiangya Hospital of Central South University), Huazhang Yang (Guangdong General Hospital), Shengli Yan (The Affiliated Hospital of Medical College Qingdao University), Zhongyan Shan (The First Hospital of China Medical University), Qiang Li (The Second Affiliated Hospital of Harbin Medical University), Zhigang Zhao (Henan Provincial People’s Hospital).