An RCT Investigating Patient-Driven Versus Physician-Driven Titration of BIAsp 30 in Patients with Type 2 Diabetes Uncontrolled Using NPH Insulin

Abstract

Introduction: The aim of this study was to confirm the efficacy of patient-driven titration of BIAsp 30 in terms of glycemic control, by comparing it to physician-driven titration of BIAsp 30, in patients with type 2 diabetes in North Africa, the Middle East, and Asia.

Methods: A 20-week, open-label, randomized, two-armed, parallel-group, multicenter study in Egypt, Indonesia, Morocco, Saudi Arabia, and Vietnam. Patients (n = 155) with type 2 diabetes inadequately controlled using neutral protamine Hagedorn (NPH) insulin were randomized to either patient-driven or physician-driven BIAsp 30 titration.

Results: The noninferiority of patient-driven compared to physician-driven titration with respect to the reduction in HbA1c was confirmed. The estimated mean change in HbA1c from baseline to week 20 was -1.27% in the patient-driven arm and -1.04% in the physician-driven arm, with an estimated treatment difference of -0.23% (95% confidence interval: -0.54; 0.08). After 20 weeks of treatment, the proportions of patients achieving the target of HbA1c <7.5% were similar between titration arms; the proportions of patients achieving the target of ≤6.5% were also similar. Both titration algorithms were well tolerated, and hypoglycemic episode rates were similar in both arms.

Conclusion: Patient-driven titration of BIAsp 30 can be as effective and safe as physician-driven titration in non-Western populations. Overall, the switch from NPH insulin to BIAsp 30 was well tolerated in both titration arms and led to improved glycemic control. A limitation of the study was the relatively small number of patients recruited in each country.

Clinical trial registration: ClinicalTrials.gov NCT01589653.

Funding: Novo Nordisk A/S, Denmark.

Keywords: Biphasic insulin aspart 30; HbA1c; NPH insulin; Titration.

Figures

Fig. 1

Patient enrollment, randomization, and analysis. PP per protocol

Fig. 2

a Mean (±SE) HbA1c levels (LOCF) over time; b observed proportions of patients who had HbA1c levels (LOCF) of <7% or ≤6.5% at week 20; c observed proportions of patients reaching HbA1c targets (LOCF) without severe and minor hypoglycemic episodes at week 20. Data from FAS. *Estimated odds ratio (95% CI) for patient-driven versus physician-driven titration. Logistic regression with treatment, stratum, region, and baseline HbA1c as explanatory variables. Minor hypoglycemic episodes were defined as episodes with symptoms consistent with hypoglycemia as confirmed by PG <3.1 mmol/L (<56 mg/dL) or full BG value <2.8 mmol/L (<50 mg/dL) and handled by the patient himself/herself, or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full BG value <2.8 mmol/L (<50 mg/dL). Severe hypoglycemia was defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. BG blood glucose, CI confidence interval, FAS full analysis set, LOCF last observation carried forward, PG plasma glucose, SE standard error

Fig. 3

a Mean change from baseline FPG (LOCF); b 7-point SMPG profiles from baseline and after 20 weeks of treatment (EOT); c total daily insulin dose. Data from FAS. EOT end of trial, FPG fasting plasma glucose, LOCF last observation carried forward, SMPG self-measured plasma glucose