Clinical Benefit of Basal Insulin Analogue Treatment in Persons with Type 2 Diabetes Inadequately Controlled on Prior Insulin Therapy: A Prospective, Noninterventional, Multicenter Study

INTRODUCTION: Basal insulin analogues offer persons with type 2 diabetes mellitus (T2DM) adequate glycemic control combined with a favorable safety profile. BASAL-BALI—a prospective, noninterventional, multicenter disease registry—assessed the effectiveness and safety of basal insulin analogues in adult Serbians with T2DM previously inadequately controlled on other insulin types. METHODS: The primary objective was to assess the reduction in glycated hemoglobin (HbA(1c)) from basal insulin analogue initiation to the end of a 6-month observation period. Data collection was performed at three study visits: baseline, 3 months, and 6 months. All treatments and procedures were performed at the physicians’ discretion. RESULTS: In total, 460 subjects were included. Mean diabetes duration was 11.6 ± 6.6 years. Late complications of diabetes were present in 67% of subjects and comorbidities in 85%. After 6 months, the mean reduction in HbA(1c) was 1.8% (p < 0.01 vs. baseline); body weight (mean reduction of 0.9 kg, p < 0.01), waist circumference (1.5 cm, p < 0.01), and BMI (0.2 kg/m(2), p < 0.01) were also reduced. A total of 49.1% of subjects reached their individualized HbA(1c) treatment target, and 42.0% met the composite HbA(1c) and fasting plasma glucose (FPG) target. The incidence of symptomatic hypoglycemia was reduced from 96.3% in the 6 months prior to initiating basal insulin analogues to 15.4% over the 6-month treatment period. CONCLUSION: Introducing basal insulin analogues in persons with T2DM previously inadequately controlled on other insulin types can significantly improve glycemic control and reduce the risk of hypoglycemia, without adversely affecting body weight. FUNDING: Sanofi, Serbia. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-018-0378-4) contains supplementary material, which is available to authorized users.