The IQ-SET India Study: A Multicentric, Retrospective, Observational Data Analysis Evaluating the Safety, Efficacy, and Tolerability of InsuQuick® (Insulin Aspart 100 U/mL) in Subjects with Type 2 Diabetes Mellitus

Background: India carries a disproportionately high burden of type 2 diabetes mellitus (T2DM), characterized by early onset, suboptimal glycemic control, and delayed insulin initiation. High treatment costs and limited access further worsen outcomes, particularly among lower-income groups. Biosimilar insulins such as InsuQuick ® (insulin aspart 100 U/mL), approved for use in India, offer an accessible and affordable alternative. Objective: To evaluate the real-world safety, effectiveness, and tolerability of InsuQuick ® (insulin aspart 100 U/mL), a biosimilar rapid-acting insulin, in Indian adults with inadequately controlled T2DM. Materials and Methods: A retrospective, multicentric, observational study was conducted across 25 Indian clinical sites. Adults aged 18–65 years with T2DM and baseline glycated hemoglobin (HbA1c) between 7.1% and 12.0% were included. All received InsuQuick ® as part of ongoing diabetes management, newly initiated or continued at the physician’s discretion. Glycemic outcomes were evaluated over 16 weeks. Results: Of 477 patients, 69.2% achieved HbA1c < 7.1%. Mean reductions were observed in HbA1c (−1.95%), fasting plasma glucose (−57.1 mg/dL), and postprandial glucose (−102.2 mg/dL; P < 0.0001). Efficacy was consistent across subgroups with varying disease duration, comorbidities, or prior basal insulin use. Adverse events occurred in 6.1%, including 1.3% with mild hypoglycemia; none were serious. Conclusion: InsuQuick ® demonstrated consistent and clinically meaningful glycemic improvements across diverse patient subgroups in real-world Indian settings. Its favorable safety profile and effectiveness suggest its potential as an accessible, cost-effective alternative for insulin intensification in routine clinical care. These findings support broader adoption of biosimilar insulin therapies to address the diabetes burden in low-resource settings.