Objectives: The objective of this study was to compare initiation of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) vs insulin glargine U100 (iGlar) along with gliclazide, exclusively in people of South Asian origin with type 2 diabetes (T2D).
Methods: The Variability of glucose Assessed in a Randomized trial comparing the Initiation of A Treatment approach with biosimilar basal Insulin analog Or a titratable iGlarLixi combinatioN in type 2 diabetes among South Asian participants (VARIATION 2 SA) trial (ClinicalTrials.gov identifier: NCT03819790) randomized insulin-naïve adults with T2D having glycated hemoglobin (A1C) 7.1% to 11% to initiate either iGlarLixi or iGlar + gliclazide. Insulin doses were titrated similarly to a prebreakfast glucose target of 4.0 to 5.5 mmol/L. Average time in range (TIR) on a masked continuous glucose monitor (CGM), A1C, fasting plasma glucose (FPG) and weight were assessed at the end of the 12-week treatment period.
Results: Mean baseline characteristics for the 104 randomized participants were similar between treatment groups, including the following: age, 59±11 years; diabetes duration, 13.7±7.3 years; and A1C, 8.5%±1.2%. Coprimary outcomes of average TIRs within 24- and 12-h (6 am to 6 pm) periods at the end of trial were 70.5%±16.8% and 72.9%±17.6% for iGlarLixi, whereas these TIRs were 65.6%±21.6% and 67.3%±20.7% for the iGlar + gliclazide regimen, respectively, with no significant differences between groups (p=0.35 for 24-h TIR and p=0.14 for 12-h TIR). No significant difference in secondary outcomes was observed between treatment groups. Self-reported hypoglycemic events throughout the trial period and CGM-reported hypoglycemia (<4 and <3 mmol/L) were similar between randomized treatments.
Conclusions: Initiation of iGlarLixi resulted in similar TIR, A1C, FPG, weight and hypoglycemia compared with the more affordable option of starting iGlar + gliclazide in adults of South Asian origin with T2D.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jcjd.2022.02.003 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia.
Indian J Crit Care Med
January 2025
Department of Anaesthesia, ICU and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Aim And Background: Hyperglycemia is a serious condition and associated with an increased risk of complications and mortality in both critically ill and non-critically ill people. Improvement in the glycemic level reduces the length of hospital stay, systemic infections and short- and long-term mortality. The aim was to test the effectiveness of insulin degludec vs insulin glargine and regular insulin in controlling blood sugar in patients with critical hyperglycemia.
View Article and Find Full Text PDFAnxiety and Body Image Distress in a Type 1 Diabetes Patient With Insulin-Induced Lipodystrophy.
Cureus
December 2024
Emergency Department, Bahria International Hospital, Rawalpindi, PAK.
This case report presents a rare instance of a 28-year-old female patient with insulin-induced abdominal lipodystrophy, who presented to the emergency department with symptoms of an anxiety attack triggered by body image distress. She was diagnosed with type 1 diabetes at the age of eight years. For the past 10 years, she has been using insulin glargine and insulin lispro, injecting roughly five times per day.
View Article and Find Full Text PDFEffectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial.
Diabetes Obes Metab
January 2025
Medical Care Center Endocrinology and Diabetology, Düsseldorf, Germany.
Aims: This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice.
Materials And Methods: This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%-10.
Newer Insulin Preparations and Insulin Analogs.
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 PDFCell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS 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 PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!