"Insulin glargine"

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                            Semglee (insulin glargine) Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * FrançaisSearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs
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                            Insulin glargine (Semglee) - Type 1 or Type 2 diabetes mellitus Skip to main contentSkip to "About this site"Government of CanadaSearch and menusSearch and menusYou are here:HomeAll ServicesHealthDrugs, health & consumer productsReview DecisionsSummary Basis of Decision - - Health CanadaDrugsNatural Health ProductsMedical DevicesReview Decisions Submit a report Prescription Drug ListAbout Expand
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                            2022Appropriate Care Guides, Agency for Care Effectiveness (Singapore)
                            Review Analysis
                            Appears Promising
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                            High-strength insulin glargine for treating type 1 and 2 diabetes mellitus ACE Technology Guidances A Singapore Government Agency Website SEARCH Who We Are Organisational Structure Advisory Committees Committees We Serve Careers at ACE Healthcare Professionals ACE Clinical Guidances (ACGs) ACE CUES ACE Technology Guidances ACE Horizon Scanning Patients & Community Asthma Resources Plain English not recommended listing insulin glargine 300 units/ml on the Standard Drug List (SDL) for treating type 1 and 2 diabetes mellitus in view of unfavourable cost-effectiveness compared with insulin glargine 100 units/ml at the price proposed by the manufacturer, and low clinical need. High-strength insulin glargine for treating type 1 and 2 diabetes mellitus (1 Apr 2022) High-strength insulin glargine
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                            2024obesity & metabolism
                            Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study. To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product
                            5
                            2024Diabetic Medicine
                            An exploratory analysis of the cost-effectiveness of insulin glargine 300 units/mL versus insulin glargine 100 units/mL over a lifetime horizon using the BRAVO diabetes model. This analysis assessed the cost-effectiveness of insulin glargine 300 units/mL (Gla-300) versus insulin glargine 100 units/mL (Gla-100) in insulin-naïve adults with type 2 diabetes (T2D) inadequately controlled with oral
                            6
                            2023Endocrine journal
                            Endocrinological evaluation of dawn phenomenon in patients with diabetes and comparison of insulin glargine U-100 biosimilar (Insulin Glargine BS Injection "Lilly") and glargine U-300 (Lantus XR): a randomized controlled study. We investigated the pathophysiology of the dawn phenomenon by examining the effects of changes in blood glucose levels from late night to early morning on various hormones
                            7
                            2025obesity & metabolism
                            Analysis of patient characteristics and safety of insulin glargine U300 use in 21 359 patients with type-2 diabetes and chronic kidney disease: DPV registry study. Managing type-2 diabetes (T2D) in chronic kidney disease (CKD) patients requires consideration of kidney function, and many drugs have not been investigated thoroughly. Clinical studies have demonstrated Glargine U300 (Gla-300
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                            2025obesity & metabolism
                            Comparative effectiveness of insulin glargine, glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors in veterans with type 2 diabetes. To compare the risk of all-cause death and cardiovascular events in new users of insulin glargine, glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i), particularly in subgroups defined by baseline haemoglobin A1C (HbA1C), body mass index (BMI) and estimated glomerular filtration rate (eGFR). We conducted an active comparator, new user design study in a national cohort of 161 405 veterans with type 2 diabetes (T2D) on metformin and initiated insulin glargine (n = 54 375), GLP-1RA (n = 22 145) or SGLT2i (n = 84 885) between 1 January 2018 and 31 December 2021. Patients
                            9
                            2021EvidenceUpdates
                            Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with insulin glargine (Lantus; IGlar) combined with oral antihyperglycaemic medications (OAMs) in insulin-naive Chinese patients with type 2
                            10
                            2021EvidenceUpdates
                            Comparable efficacy and safety between LY2963016 insulin glargine and insulin glargine (Lantus(R)) in Chinese patients with type 1 diabetes: A phase III, randomized, controlled trial To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with the reference product (Lantus®) insulin glargine (IGlar) in Chinese patients with type 1 diabetes mellitus (T1DM). This phase III
                            11
                            2023Lancet
                            Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Insulin icodec (icodec) is a basal insulin analogue suitable for once-weekly dosing. ONWARDS 4 aimed to assess the efficacy and safety of once-weekly icodec compared with once-daily insulin glargine U100 (glargine U100) in individuals with long-standing type 2 diabetes on a basal-bolus regimen. In this 26-week, phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial, adults from 80 sites (outpatient clinics and hospital departments) across nine countries (Belgium, India, Italy, Japan, Mexico, the Netherlands, Romania
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                            2023EvidenceUpdates
                            Diabetes remission and relapse following an intensive metabolic intervention combining insulin glargine/lixisenatide, metformin and lifestyle approaches: Results of a randomised controlled trial Non-surgical options for inducing type 2 diabetes remission are limited. We examined whether remission can be achieved by combining lifestyle approaches and short-term intensive glucose-lowering therapy . In this trial, 160 patients with type 2 diabetes on none to two diabetes medications other than insulin were randomised to (a) an intervention comprising lifestyle approaches, insulin glargine/lixisenatide and metformin, or (b) standard care. Participants with glycated haemoglobin (HbA1c) <7.3% (56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for an additional 52 weeks
                            13
                            2023EvidenceUpdates
                            Effects of Tirzepatide Versus Insulin Glargine on Cystatin C-Based Kidney Function: A SURPASS-4 Post Hoc Analysis Tirzepatide reduces HbA1c and body weight, and creatinine-based estimated glomerular filtration rate (eGFR) decline. Unlike creatine-derived eGFR (eGFR-creatinine), cystatin C-derived eGFR (eGFR-cystatin C) is unaffected by muscle mass changes. We assessed effects of tirzepatide on eGFR-creatinine and eGFR-cystatin C. Our primary outcome was eGFR change from baseline at 52 weeks with pooled tirzepatide (5, 10, and 15 mg) and titrated insulin glargine in adults with type 2 diabetes and high cardiovascular risk (SURPASS-4). Least squares mean (SE) eGFR-creatinine (mL/min/1.73 m2) changes from baseline with tirzepatide and insulin glargine were -2.5 (0.38) and -3.9 (0.38) (between
                            14
                            2018Institute for Quality and Efficiency in Healthcare (IQWiG)
                            Review Analysis
                            Appears Promising
                            ?
                            Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Insulin glargin/Lixisenatid (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 2018). Please note : This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-16 Insulin glargine/lixisenatide (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A18-16 Version
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                            Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus(®)): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial. LY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product in Chinese patients
                            16
                            2022obesity & metabolism
                            Immunogenicity of LY2963016 insulin glargine and Lantus® insulin glargine in Chinese patients with type 1 or type 2 diabetes mellitus. To evaluate the immunogenicity of LY2963016 insulin glargine (LY IGlar) versus originator insulin glargine (IGlar [Lantus®]) in Chinese patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM). ABES and ABET were prospective, randomized, active control , open-label, phase III studies, which enrolled Chinese patients with T1DM (N = 272) and T2DM (N = 536), respectively. Using data from these trials, immunogenicity of LY IGlar and IGlar was evaluated by comparing the proportion of patients with detectable anti-insulin glargine antibodies and the median antibody levels (percent binding) between the treatment groups. The incidence of anti-insulin
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                            2022Frontiers in pharmacology
                            Pharmacokinetic and pharmacodynamic similarity evaluation between an insulin glargine biosimilar product and Lantus(®) in healthy subjects: Pharmacokinetic parameters of both parent insulin glargine and M1 were used as endpoints. Insulin glargine is a long-acting insulin analog, which plays an important role in the treatment of diabetes mellitus. Biosimilar products of insulin glargine can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. This article presents a randomized, double-blind, single-dose, two-treatment, four-period, replicate crossover, euglycemic clamp study which was designed to evaluate the PK and PD similarity between the recombinant insulin glargine developed by Wanbang (test) and Lantus (reference
                            18
                            2024obesity & metabolism
                            Real-world effectiveness and safety of insulin glargine 100 U/mL plus lixisenatide in adults with type 2 diabetes: An international, multicentre, 12-month, prospective observational study. To assess the impact of insulin glargine (100 U/mL) and lixisenatide (iGlarLixi) fixed-ratio combination therapy on the overall management of glycaemia in patients with type 2 diabetes (T2D), previously
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                            Evaluation of glucose metrics in adults with type 1 diabetes switching to Insulin Glargine 300 U/mL: a retrospective, propensity-score matched study. OBJECTIVES To study real-world effect of switching to Insulin Glargine 300 U/mL (Gla-300) on glucose metrics in people with type 1 diabetes (T1D). METHODS This retrospective secondary-use study compared 151 adults who switched to Gla-300 from first
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                            Continuous Glucose Monitoring Profiles and Health Outcomes after Dapagliflozin Plus Saxagliptin vs Insulin Glargine. Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA+SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). 24-week sub-study of a randomized, open-label, two-arm, parallel-group, phase 3b study. Multicenter study (112 centers in 11 countries). 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. DAPA+SAXA vs INS. Changes in CGM profiles