Safety and Efficacy of Insuget® (Human Insulin rDNA) in the Management of Patients with Type II Diabetes Mellitus: A Prospective Observational Study
Abstract
This study aimed to assess the safety and efficacy profile of Insuget® (human insulin rDNA) in patients with T2DM. An open-label, prospective, observational, single-arm, multicenter, post-marketing surveillance study observed the safety and efficacy of Insuget® in patients with T2DM. Data on glycemic control, blood pressure, adverse events, and other relevant parameters were collected following patients for six months after initiating Insuget®. The 337 patients participated in the study, with 63.5% being males. The mean age was 53.27 ± 11.10 years. Treatment with Insuget® significantly reduced mean HbA1c and fasting blood sugar levels (p < 0.01) with a significant improvement in systolic and diastolic blood pressure. However, the mean weight significantly increased (p < 0.01). The frequency of adverse events related to hypoglycemia and hypokalemia decreased over time, whereas injection site-related adverse events increased by the last follow-up visit. Comparison with other studies revealed that the findings are consistent with earlier research on recombinant insulin. This study emphasizes the potential advantages of Insuget® in managing T2DM, particularly in individuals who have uncontrolled diabetes despite previous medications. The observed improvements in glycemic control and blood pressure highlight the relevance of recombinant insulin in diabetes care regimens. The complete evaluation of numerous parameters, including glycemic control, blood pressure, and adverse events, provides full knowledge of the safety and efficacy of Insuget® and strengthens the study. Limitations include the small sample size and the relatively short follow-up time, which make it difficult to draw conclusive conclusions. Additional studies, including varied individuals and direct comparisons with alternative insulin formulations, should improve the knowledge of Insuget® comparative efficacy.
Keywords: human insulin rDNA, type II diabetes mellitus, HbA1c, hypoglycemia, hypokalemia.
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