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 (HbA1c ) measurement and CGM were performed at enrollment and at the end of each treatment stage.

RESULTS: BHG's contribution rate increased with increasing HbA1c (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 HbA1c levels < 7.5%. Compared with LM50, LM25 shows a significant difference in reducing HbA1c in the subgroup with baseline HbA1c  ≥ 8.5% (ΔHbA1c 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 HbA1c  < 8.5%, while fasting hyperglycemia became the major contributor to overall hyperglycemia in the subgroup of patients with HbA1c  ≥ 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).