Contribution of BHG and PPHG to Overall Hyperglycemia in T2DM Patients Treated with LM25 and LM50: Post Hoc Analysis of a Randomized Crossover Trial.

INTRODUCTION

To investigate the relative contribution rates of basal hyperglycemia (BHG) and postprandial hyperglycemia (PPHG) to overall hyperglycemia in patients with type 2 diabetes mellitus (T2DM) treated with insulin lispro mix 25 and 50 (LM25 and LM50) as evaluated by continuous glucose monitoring (CGM).

METHODS

Eighty-one T2DM patients treated with premixed human insulin 70/30 (PHI70/30) were randomly divided into two groups and received a crossover protocol. In the first 16-week stage, one group received LM25 twice daily, the other group received LM50 twice daily. In the second 16-week stage, the two groups exchanged therapeutic regimen. Glycosylated hemoglobin (HbA) measurement and CGM were performed at enrollment and at the end of each treatment stage.

RESULTS

BHG's contribution rate increased with increasing HbA (from 34.5% to 60.8%). PPHG's contribution rates in the LM50 regimen were significantly lower than those in LM25 and PHI70/30 regimens at HbA levels < 7.5%. Compared with LM50, LM25 shows a significant difference in reducing HbA in the subgroup with baseline HbA ≥ 8.5% (ΔHbA LM25 vs. LM50 - 0.6 ± 0.1% vs. 0.3 ± 0.1%, p < 0.05).

CONCLUSIONS

For T2DM patients treated with premixed insulin analogues, postprandial hyperglycemia played a major role in the subgroup of patients with HbA < 8.5%, while fasting hyperglycemia became the major contributor to overall hyperglycemia in the subgroup of patients with HbA ≥ 8.5%.

TRIAL REGISTRATION

Chinese Clinical Trial Registry Identifier ChiCTR-TTRCC-12002516.

FUNDING

Lilly Suzhou Pharmaceutical Co., Ltd. (Shanghai Branch, China) and National Key Program of Clinical Science of China (WBYZ2011-873).