Purpose: The aims of this study were to use real-world treatment results to compare changes in estimated glomerular filtration rate (eGFR) and glycosylated hemoglobin (HbA) among patients with type 2 diabetes who initiated treatment with dulaglutide or insulin glargine and to determine the proportions of patients with renal impairment who initiate each treatment.
Methods: The study used data from the Practice Fusion electronic health records database from October 2013 through June 2017. Adults with type 2 diabetes who initiated dulaglutide or insulin glargine therapy and had multiple recorded serum creatinine and/or HbA laboratory test results were included in the study. The dulaglutide cohort (n = 1222) was matched to the insulin glargine cohort (n = 13,869) using Mahalanobis distance matching with propensity score calipers. Multivariable analyses of the matched cohorts of individuals with serum creatinine results (n = 1183 dulaglutide and 1183 insulin glargine) examined the association between intent-to-treat therapy and changes in eGFR. In addition, multivariable analyses were also conducted on a subset of these patients who also had recorded HbA tests (n = 1088 dulaglutide and 1088 insulin glargine) to examine the association between changes in HbA during the 1 year postperiod.
Findings: Among patients who initiated dulaglutide therapy, only 0.9% of patients had an index eGFR <30 and ≥15 mL/min/1.73 m and 0.1% had an index eGFR <15 mL/min/1.73 m. In contrast, 4.1% of insulin glargine-treated patients had an index eGFR <30 and ≥15 mL/min/1.73 m and 1.2% had an index eGFR <15 mL/min/1.73 m. Compared with patients who initiated therapy with insulin glargine, initiation of dulaglutide therapy was associated with a significantly smaller decrease in eGFR (-0.4 vs -0.9 mL/min/1.73 m; P = 0.0024), a significantly smaller likelihood of having a 30% or greater reduction in eGFR (3.3% vs 4.1%; P < 0.0001), and a significantly larger reduction in HbA (-0.5% vs -0.2%; P < 0.0001).
Implications: In clinical practice, the use of dulaglutide was relatively more limited in patients with a higher degree of renal impairment compared with use of insulin glargine. However, initiation of dulaglutide therapy, compared with insulin glargine therapy, was associated with a significantly smaller decrease in eGFR and a larger reduction in HbA during the 1 year postperiod.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.clinthera.2018.07.002 | 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.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!