Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naïve subjects with type 2 diabetes

Abstract

Objective:

To investigate whether once daily biphasic insulin aspart 30 (BIAsp 30) is noninferior to once daily insulin glargine (IGlar) among Chinese and Japanese insulin-naïve subjects with type 2 diabetes mellitus (T2DM).

Research design and methods:

This was a 24 week treat-to-target trial (NCT01123980) that included patients with T2DM who were poorly controlled on a combination of metformin and insulin secretagogue (or with a maximum of one more OAD) for 6 months. Patients were randomized to once daily BIAsp 30 or once daily IGlar and their secretagogue standardized to glimepiride 4 mg/day, metformin to 1500 or 2500 mg/day before randomization.

Results:

At Week 24, mean change from baseline in HbA1c was −0.78 ± 0.88% (mean ± SD) and −0.65 ± 0.92% (−8.49 ± 9.65 and −7.08 ± 10.1 mmol/mol) for the BIAsp 30 (n = 261) and IGlar (n = 260) groups, respectively. The estimated between-group difference (BIAsp 30 vs IGlar) in HbA1c change was −0.12% (95% CI: −0.25, 0.02) (−1.28 mmol/mol [95% CI: −2.75, 0.19]), thus treatment with BIAsp 30 was noninferior to IGlar with respect to HbA1c (non-inferiority margin 0.4%). Although reduction in mean 9-point self-measured plasma glucose (SMPG) profile was comparable between the two groups, BIAsp 30 showed significantly lower PG levels at three time points post-dinner and a higher PG level before dinner compared to the IGlar group (all p < 0.05). Comparable number of subjects reported hypoglycemic events (155 [59.4%] for BIAsp 30, 148 [56.9%] for IGlar).

Conclusions:

BIAsp 30 once daily showed similar HbA1c reduction and a similar safety profile to IGlar when used in insulin-naïve Chinese and Japanese patients on metformin and a sulfonylurea. Moreover, it provided a better coverage of post-dinner glycemic control needs than those who received IGlar. The open-label design and insufficient insulin dose titration were the main limitations of the study.

Trial registration: ClinicalTrials.gov identifier: NCT01123980.

Keywords::

• Biphasic insulin aspart 30
• Insulin glargine
• Insulin initiation
• Insulin naïve
• Insulin therapy
• Type 2 diabetes mellitus

Transparency

Declaration of funding

Funding to support this study and the preparation of this manuscript was provided by Novo Nordisk A/S. The company was responsible for monitoring the trial, providing clinical trial supplies, performing the statistical analyses, and preparing a clinical trial report. The authors had full access to all the data and take responsibility for the accuracy of the data and its analysis.

All authors made a significant contribution to this work, reviewed the final manuscript, and approved its submission. Specific contributions – W.Y.: conduct/data collection, analysis, writing manuscript; X.X.: conduct/data collection, analysis, writing manuscript; X.L.: conduct/data collection, analysis, writing manuscript; G.Y.: conduct/data collection, analysis, writing manuscript; Y.S.: conduct/data collection, analysis, writing manuscript; H.A.: design, analysis, writing manuscript; H.J.: conduct/data collection, analysis, writing manuscript.

Declaration of financial/other relationships

H.A. is an employee of the study funder. Y.S. and H.J. are advisors to Novo Nordisk. W.Y., X.X., X.L., and G.Y. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors thank Xiaowei Ren and Ningning Qu of Novo Nordisk China for performing statistical analysis, and Aric Fader PhD of MedVal Scientific Information Services LLC and Yue Ma of Novo Nordisk China for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: The GPP2 Guidelines’.