Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study

Abstract

Aims:

To explore safety and efficacy of BIAsp 30 as initiation or replacement therapy in routine clinical practice in patients with poorly controlled diabetes in the Chinese cohort of the IMPROVE study.

Methods:

In the 26-week, non-interventional, observational study, Chinese subjects with diabetes started BIAsp 30 treatment in routine care. Data from patients’ diaries and medical records were transferred to CRFs by participating physicians.

Clinical trial registration:

NCT00659282.

Results:

Of the 21,729 subjects enrolled (mean age 54.0 years, BMI 24.6 kg/m², diabetes duration 4.86 years), 32.3% were treatment-naïve, 59.3% were from oral anti-diabetic drugs (OADs) only and 8.1% were from insulin ± OADs. Overall, mean HbA_1c and FBG decreased by 2.82% and 5 mmol/L, respectively. In the subgroups, changes were: −3.27% and −6.06 mmol/L (treatment-naïve), −2.57% and −4.54 mmol/L (OADs only), −2.96% and 3.51 mmol/L (insulin ± OADs) all p < 0.05. HbA_1c < 7% was achieved by 71.4% of patients. Only 0.1% of subjects reported major hypoglycaemia and 73 SADRs were observed without significant difference compared to those at baseline. Body weight did not change significantly.

Conclusions:

Regardless of previous treatments, insulin initiation or replacement with BIAsp 30 improved glycaemic control without increasing major hypoglycaemia or weight gain in Chinese patients with diabetes.

Key words::

• BIAsp 30
• China
• Observational study
• Routine practice

Transparency

Declaration of funding

This trial was financially supported by Novo Nordisk.

Declaration of financial relationship

All of the authors have disclosed that they have no relevant financial relationships.

Peer reviewers may receive honorariums from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she has acted as a consultant/advisor to Novo Nordisk. Peer Reviewer 2 has disclosed that he/she has received speakers bureau honoraria from Takeda and MSD.

Acknowledgements

The authors acknowledge contributions from the following Novo Nordisk employees: Hongfei Xu, Jing Lian and Jun Wang for general coordination of the trial; Yan Zhou for proofreading and editorial support.

The authors wish to thank and acknowledge the work of the staff at all participating hospitals and clinical laboratories. The Chinese cohort of the IMPROVE study included the following investigators: Wenying Yang (China–Japan Friendship Hospital, Beijing, China), Yan Gao (The First Affiliated Hospital, Peking University, China), Guoliang Liu (The First Affiliated Hospital, China Medical University, China), Lulu Chen (The Union Hospital, Huazhong Technology University, China), Zuzhi Fu (The Second Affiliated Hospital of Sun Yat-sen University, China), Dajin Zou (The Changhai Hospital, The Second Military Medical University, China), Ping Feng (Tianjin Medical University General Hospital, China), Zhigang Zhao (Henan Provincial People's Hospital, China).

Data reported in this article were previously presented in the abstract book of the Huaxia Endocrinology Conference, Taipei, Taiwan, 4–9 December 2008.

Notes

* NovoMix 30 is a registered trademark of the NovoNordisk group.