Diabetes mellitus has reached epidemic proportions worldwide, eliciting extensive research on both the disease process and its treatment. Regardless of diabetes type, the progressive nature of the disease makes insulin the long-term mainstay of diabetes management. Recently, the insulin analog glargine was reported in several epidemiologic studies to be associated with an increased risk of cancer. Inconsistent study results and media attention have caused much angst and concern to health care professionals and the general population. A clear understanding of the current evidence is needed to adequately develop a patient-oriented risk:benefit assessment. Members of the Endocrine and Metabolism Practice and Research Network of the American College of Clinical Pharmacy evaluated available evidence to provide guidance and discussion on the risk of cancer with insulin glargine use. We believe the current link between insulin glargine and cancer is tenuous but merits further evaluation. An independent analysis of all available glargine clinical trial data should be performed, and a vigorous postmarketing safety study of glargine should be conducted. Until more substantial data are available, however, neither the choice of initial insulin therapy nor insulin maintenance regimens should be influenced by the current information linking insulin glargine to cancer.
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http://dx.doi.org/10.1592/phco.30.9.955 | DOI Listing |
Cureus
November 2024
Department of Pharmacology, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad, IND.
Diabetes mellitus represents a significant and growing global health challenge, with its prevalence steadily increasing. Insulin therapy remains a cornerstone of diabetes management. Since its discovery in 1921, insulin has undergone substantial advancements, evolving from crude animal extracts to highly refined recombinant formulations and biosimilars.
View Article and Find Full Text PDFAAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFDiabetes Ther
December 2024
Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Introduction: ONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).
View Article and Find Full Text PDFDiabetes Obes Metab
December 2024
Sanofi Investment Co., Ltd., Shanghai, China.
Aims: To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with uncontrolled type 2 diabetes (T2D) switching from another basal insulin (BI).
Materials And Methods: INITIATION was an interventional, single-arm, phase IV study conducted in China. In this post hoc subpopulation analysis, the efficacy and safety of switching to Gla-300 was investigated in individuals with uncontrolled T2D (HbA1c 7.
Endocr Pract
December 2024
Department of Endocrinology, CEDAR Superspeciality Clinics, Dwarka, New Delhi, India.
Objective: No meta-analysis has been published comparing the efficacy and safety of tirzepatide vs once-daily basal insulins in subjects with type 2 diabetes (T2D) inadequately controlled with oral anti-hyperglycemic drugs. This meta-analysis was conducted to address this knowledge gap.
Methods: Randomized controlled trials involving subjects with T2D inadequately controlled with oral anti-hyperglycemic drugs and receiving tirzepatide in intervention arm and basal insulins in control arm as add-on therapy were searched throughout the electronic databases.
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