A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience

Abstract

Introduction: According to Chinese guidelines, basal insulin (BI) or premixed insulins are recommended insulin starters following the failure of oral antihyperglycemic medication (OAM) in Chinese patients with type 2 diabetes (T2D). This pragmatic study investigated the long-term effectiveness, safety, and cost of add-on BI and mid-mixture insulin analog (MMI) regimens in Chinese patients with T2D.

Methods: This multicenter, open-label, pragmatic study randomized patients 1:1 to receive either BI or MMI with OAMs adjusted according to current standards of care. We evaluated the change in glycated hemoglobin (HbA1c) from baseline, safety parameters, and antidiabetic medication costs.

Results: Change in HbA1c from baseline showed a statistically greater decrease at week 48 in the MMI group (MMI: - 2.03% [0.06] vs. BI: - 1.82% [0.06]; P < 0.05). Both groups showed decreases in fasting plasma glucose (mmol/L) (MMI: - 2.53 [0.14] vs. BI: - 3.19 [0.14]; P < 0.01) and postprandial glucose (mmol/L) (MMI: - 4.35 [0.22] vs. BI: - 4.33 [0.23]). More patients in the BI group showed increases in OAM use, while OAM use decreased in the MMI group. Both groups showed stable glycemic control with a very limited insulin dose change from week 24 to week 48. The incidence of total hypoglycemia was higher in the MMI group (MMI: 124% [30.7] vs. BI: 76% [18.5], P < 0.0001), but no incidence of severe hypoglycemia was reported in either group. Treatment costs, in terms of average daily cost and cost of glycemic control, were higher in the BI group.

Conclusion: In long-term real-world use, the MMI and BI groups demonstrated improved glycemic control, with the MMI group showing more significant improvement than the BI group. Hypoglycemia incidence was higher in the MMI group, with no major safety issues through week 48. MMI is likely to provide better price value than BI for the treatment of T2D in Chinese patients.

Trial registration: ClinicalTrials.gov identifier: NCT03018938.

Keywords: Basal insulin; Chinese patients; Premixed insulin; Real-world study; Type 2 diabetes.

Figures

Fig. 1

Patient disposition. †Six patients failed the screening process but were randomized. ‡Two patients did not have a reason for discontinuation. N total population, n number of patients in each category

Fig. 2

Changes in HbA1c at week 48 from baseline using analysis of covariance. †LSM difference (95% CI) between MMI + OAM (MMI group) and BI + OAM (BI group). LSM values and P-values are based on an analysis of covariance model. BI basal insulin, CI confidence interval, HbA1c glycated haemoglobin, LSM least-squares mean, MMI mid-mixture insulin, OAM oral antihyperglycemic medication, SE standard error