metformin/glyburide / Generic mfg. - LARVOL DELTA

CER-4-T2D: Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study (clinicaltrials.gov) - P=N/A | N=781430 | Active, not recruiting | Sponsor: Brigham and Women's Hospital | Trial completion date: Jul 2024 ➔ Jul 2026 | Trial primary completion date: Jul 2024 ➔ Jan 2026

HEOR • Trial completion date • Trial primary completion date • Cardiovascular • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

MicroRNAs modulated by DPP-4 inhibitor and bedtime NPH insulin therapy in individuals with type 2 diabetes. (PubMed, Front Endocrinol (Lausanne)) - "To evaluate the effects of bedtime NPH insulin and sitagliptin on serum miRNA expression in individuals with type 2 diabetes (T2D), thirty-two patients with T2D inadequately controlled with metformin and glyburide were randomly assigned to an additional 6-month treatment with either bedtime NPH insulin or sitagliptin. Sitagliptin and bedtime NPH insulin induced metabolic improvement and distinct modulation of circulating miRNAs, with sitagliptin influencing a broader spectrum of miRNA expression. The upregulated miRNAs are involved in pathways related to insulin signaling, inflammation, and cellular homeostasis and support the hypothesis that sitagliptin exerts pleiotropic effects beyond glycemic control."

Clinical • Journal • Atherosclerosis • Cardiovascular • Diabetes • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • MicroRNA 30c • MIR193B • MIR27A • MIR320A • MIR660

Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin-Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling. (PubMed, Pharmaceutics) - "The dissolution safe space for the FDC was defined as the concurrent achievement of ≥ 50% dissolution within 25 min for metformin and between 35 and 170 min for glyburide, which constituted equivalent specification. The PBBM developed in this study systematically evaluated the VBE of metformin-glyburide FDC, optimized the acceptance criteria for traditional in vitro dissolution testing, and thereby explored its clinically relevant quality specification."

Journal • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders

Efficacy of glyburide vs. metformin in preventing neonatal birth obesity in pregnancies complicated by gestational diabetes mellitus: a systematic review and meta-analysis. (PubMed, Front Pediatr) - "Given these concerns, a comprehensive evaluation of treatment options, including glyburide and metformin, compared to insulin, is essential to guide clinical practice. Consistent with these findings, glyburide was associated with an increase in infant birth weight, while metformin was associated with a decrease. These findings emphasize the importance of personalized treatment strategies for GDM management."

Journal • Retrospective data • Review • Diabetes • Genetic Disorders • Gestational Diabetes • Hypoglycemia • Metabolic Disorders • Obesity

A safety review of approved oral agents for treating type 2 diabetes and associated diseases in pregnant patients. (PubMed, Expert Opin Drug Saf) - "Insulin is the first-line therapy; however, adherence barriers, cost, and route of administration challenges have driven interest in oral agents like metformin and glyburide. Both agents hold promise as alternatives to insulin, particularly in resource-limited settings. However, further research is needed to address knowledge gaps, optimize their use, and ensure safe integration into clinical practice."

Adverse events • Journal • Review • Diabetes • Genetic Disorders • Gestational Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Polycystic Ovary Syndrome • Type 2 Diabetes Mellitus

Bedtime NPH Insulin and DPP-4 Enzyme Inhibitor (sitagliptin) Increase Cholesterol Removal from Macrophages (ADA 2025) - "We evaluated the effect of treatment with bedtime NPH insulin or sitagliptin on cholesterol efflux from patients with T2DM. Thirty-two patients with T2DM, inadequately controlled with metformin and glibenclamide were randomly assigned to 6-month complementary treatment with bedtime NPH insulin or sitagliptin. six-month treatment with NPH insulin or sitagliptin increased the capacity of apoB-depleted serum to mediate the removal of cholesterol from macrophages, which may contribute to the prevention of cardiovascular disease in DM. Supported by FAPESP, FMUSP, CNPq"

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Bedtime NPH Insulin Reduced the Expression of Serum miRNAs Related to Insulin Resistance in Comparison to DPP-4 Inhibitor Sitagliptin in Patients with T2DM (ADA 2025) - "We evaluated the effect of treatment with bedtime NPH insulin or sitagliptin on serum miRNAs expression of patients with T2D Thirty-two patents with T2D inadequately controlled with metformin and glibenclamide were randomly assigned to 6-month complementary treatment with bedtime NPH insulin or sitagliptin. 6-month treatment with NPH insulin or sitagliptin improved glycemic control. NPH insulin determined lower values ​​of miRNAs related to insulin resistance"

Clinical • Metabolic Disorders • Type 2 Diabetes Mellitus • MIR27A • MIR660

Glucometer ownership and plasma glucose monitoring practices among persons with type 2 diabetes mellitus on oral antihyperglycaemic therapy in Gulu, Uganda. (PubMed, Medicine (Baltimore)) - "Treatment included a combination of glibenclamide and metformin for 132 (70.6%) participants. The predominant reliance on clinic-based measurements and the high prevalence of self-reported complications, especially hypertension, underscore the need for targeted interventions to encourage regular home monitoring and enhance overall glycemic control. The observed association between tertiary education and improved glucose monitoring practices suggests that educational initiatives could be pivotal in fostering positive health outcomes in this population."

Journal • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

Oral Glucose-Lowering Agents vs Insulin for Gestational Diabetes: A Randomized Clinical Trial. (PubMed, JAMA) - "Metformin and glyburide monotherapy are used as alternatives to insulin in managing gestational diabetes. Treatment of gestational diabetes with metformin and additional glyburide, if needed, did not meet criteria for noninferiority compared with insulin with respect to the proportion of infants born large for gestational age. Netherlands Trial Registry Identifier: NTR6134."

Clinical • Journal • Cardiovascular • Critical care • Diabetes • Gestational Diabetes • Gynecology • Hepatology • Hypertension • Hypoglycemia • Metabolic Disorders

Efficacy and safety of pharmacological treatments for gestational diabetes: a systematic review comparing metformin with glibenclamide and insulin. (PubMed, Diabetes Metab) - "Metformin appears to be a promising alternative to insulin for treating gestational diabetes, while uncertainties remain regarding the safety of glibenclamide."

Journal • Review • Cardiovascular • Critical care • Diabetes • Gestational Diabetes • Gynecology • Hypertension • Hypoglycemia • Metabolic Disorders

Risk of Suicide, Hair Loss, and Aspiration with Glucagon-like Peptide 1 Receptor Agonists: A Real-World Pharmacovigilance Study from the FAERS database (AHA 2024) - "GLP1-RAs were the most reported class with hair loss [ROR= 0.605 (95% CI 0.6 - 0.64)], and semaglutide, liraglutide, and dulaglutide were the three leading medications. GLP1-RAs ranked lower with aspiration events, which were led by sitagliptin and DPP4i as a group. GLP1-RAs exhibit higher reporting of suicide, hair loss, and aspiration events when compared to several other antidiabetic medications, despite not meeting the criteria for positive signals yet. This warrants intensive monitoring and reporting."

Adverse events • Clinical • Real-world • Real-world evidence • Alopecia • Diabetes • Metabolic Disorders

Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes (clinicaltrials.gov) - P=N/A | N=180 | Not yet recruiting | Sponsor: Assiut University

New trial • Diabetes • Gestational Diabetes • Metabolic Disorders

Impact of hospital-community diabetes management intervention in Central Region, Ghana: A retrospective study. (PubMed, Diabetes Res Clin Pract) - "The intervention achieved significant reduction in blood glucose levels. Patients with diabetes benefit from the hospital-community link diabetes management intervention regarding glycaemic control."

Journal • Retrospective data • Diabetes • Metabolic Disorders

Assessment of subclinical left ventricular systolic and diastolic dysfunction in patients with type 2 diabetes mellitus under follow-up at Tikur Anbessa specialized hospital, Ethiopia: a case-control study. (PubMed, BMC Cardiovasc Disord) - "Left ventricular systolic and diastolic dysfunction were significantly more prevalent among diabetic patients than their sex- and age-matched controls in our study. We recommend early screening for subclinical left ventricular dysfunction, especially in the elderly and in those with chronic kidney disease, dyslipidemia, and microvascular complications such as neuropathy."

Journal • Cardiovascular • Chronic Kidney Disease • Diabetes • Dyslipidemia • Heart Failure • Metabolic Disorders • Nephrology • Pain • Renal Disease • Type 2 Diabetes Mellitus

Novel Activity of Oral Hypoglycemic Agents Linked with Decreased Formation of Tryptophan Metabolite, Kynurenic Acid. (PubMed, Life (Basel)) - "Here, the effects of metformin and glibenclamide on the brain synthesis of kynurenic acid were evaluated. The reduced availability of kynurenic acid may be regarded as an unwanted effect, possibly alleviating the neuroprotective action of oral hypoglycemic agents. On the other hand, considering that both compounds ameliorate the cognitive deficits in animal and human studies and that high brain kynurenic acid may hamper learning and memory, its diminished synthesis may improve cognition."

Journal • Cardiovascular • CNS Disorders • Cognitive Disorders • Diabetes • Inflammation • Metabolic Disorders • Psychiatry

A Comprehensive Review of Gestational Diabetes Mellitus: Impacts on Maternal Health, Fetal Development, Childhood Outcomes, and Long-Term Treatment Strategies. (PubMed, Cureus) - "Although new oral medications for diabetes management, such as glyburide and metformin, show potential, there are ongoing worries regarding their safety over an extended period for both the mother and the child. By identifying gaps in the research, it calls for further investigations and a multidisciplinary approach, ultimately aiming to enhance the management and care for women with GDM, which would impact these affected individuals indubitably."

Journal • Review • Cardiovascular • Diabetes • Genetic Disorders • Gestational Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Obstetrics • Type 2 Diabetes Mellitus

Cutaneous Leukocytoclastic Vasculitis Induced By Vildagliptin – Case Report (WCD 2023) - "Her past medical history was positive for Hypertension treated with Enalarpil for the last 6 years, and Diabetes Mellitus treated with Metformin and Glibenclamide since 4 years ago, but 11 days prior the initial symptoms, she was changed to oral tablets of Vildagliptin 50mg. KEY MESSAGE: Pluripotential effects from DPP – 4 inhibitors have been described, as modifiers of immune response, antigenic effects in the basal membrane zone, eosinophilic activation in dermis and activation of CD26 receptor. A closer watch of cutaneous side effects of this drug is recommended"

Clinical • Allergy • Cardiovascular • Diabetes • Hematological Disorders • Hypertension • Immunology • Metabolic Disorders • Vasculitis • DPP4

Hemiballismus - A Rare Presentation Of Uncontrolled Diabetes Mellitus Type 2 (ENDO 2023) - "She has Diabetes Mellitus Type 2 for the past 20 years on Glibenclamide and Metformin...For the hemiballism and other neurologic manifestations such as agitation, visual hallucinations and disorientation patient was given risperidone and clonazepam...This shows the importance of prompt blood glucose measurement in these acute cases. Once identified, adequate glycemic control through insulin therapy remains to be the center and most effective therapeutic management for the resolution of these hyperkinetic symptoms."

Late-breaking abstract • Cerebral Hemorrhage • CNS Disorders • Diabetes • Hematological Disorders • Metabolic Disorders • Movement Disorders • Rare Diseases • Type 2 Diabetes Mellitus • Vascular Neurology

Undiagnosed MODY in Case of Morbid Obesity (ENDO 2023) - "Glyburide and Metformin were started that improved his glucose level significantly...Her current glucose level is normal on Glyburide 2.5 mg and pioglitazone 7.5 mg daily... Patient and his mother had heterozygous gene polymorphism in GLIS3, c.951G>T (p.Glu317Asp). This sequence replaces glutamic acid with aspartic acid at codon 317 of the GLIS3 protein (p.Glu317Asp). GLIS3 is a variant of MODY and is a transcriptional factor in beta cell differentiation and insulin production."

Clinical • Diabetes • Diabetic Nephropathy • Diabetic Neuropathy • Genetic Disorders • Gestational Diabetes • Hypertriglyceridemia • Obesity • Pain • Renal Disease • Type 1 Diabetes Mellitus • NTRK2

Metformin is comparable to insulin for pharmacotherapy in gestational diabetes mellitus: A network meta‐analysis evaluating 6046 women (QDEM-7 2023) - "Objective: The aim of this study was to compare the efficacy of metformin and glibenclamide to insulin using a core outcome set (COS) to unify outcomes across trials investigating the treatment of gestational diabetes mellitus. Metformin is, at least, comparable to insulin for the treatment of GDM. Glibenclamide appears less favorable, in comparison to insulin, than metformin."

Retrospective data • Cardiovascular • Diabetes • Gestational Diabetes • Gynecology • Hypertension • Hypoglycemia • Metabolic Disorders

Medications for Managing Preexisting and Gestational Diabetes in Pregnancy. (PubMed, Obstet Gynecol Clin North Am) - "Metformin and glyburide are the most commonly used oral agents in pregnancy. Understanding each medication's unique pharmacokinetics, potential side effects, fetal or childhood risks, gestational age of medication initiation and patient's diabetes care barriers are important aspects of shared decision-making and choosing a regimen that will achieve glycemic and pregnancy goals."

Journal • Review • Diabetes • Gestational Diabetes • Metabolic Disorders

Co-administration of metformin and/or glibenclamide with losartan reverse N-nitro-l-arginine-methyl ester-streptozotocin-induced hypertensive diabetes and haemodynamic sequelae in rats. (PubMed, Microvasc Res) - "Additionally, l-NAME + STZ-induced degeneration of pancreatic islet and myocardial cells were dramatically alleviated by losartan + metformin + glibenclamide treatments. Our findings suggest hyperglycemia with raised systolic-BP should be managed with losartan combined with both metformin and glibenclamide than single combination of losartan with antidiabetics."

Journal • Preclinical • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders

Signal Suppression in LC-ESI-MS/MS from Concomitant Medications and Its Impact on Quantitative Studies: An Example Using Metformin and Glyburide. (PubMed, Molecules) - "The stable isotope-labeled internal standard could play a role in correction and improve the quantitative accuracy of GLY, which was further confirmed in the pharmacokinetic study of simulated samples. This study provided an example model to illustrate the possible effect of clinical drug combination on LC-MS/MS drug quantitative analysis and investigated the effective methods to solve this problem."

Journal

Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions. (PubMed, Clin Pharmacol Drug Dev) - "The aim of this study was to evaluate the bioequivalence and safety of metformin hydrochloride and glibenclamide tablets (500 mg/5 mg) prepared by 2 different vendors in healthy Chinese subjects under fasting and fed conditions. It was found that exposure (AUC from time 0 to infinity) to metformin is decreased by about 25% in the fed state compared to fasting, whereas glibenclamide exposure is increased by about 30% in the fed state. No severe adverse events were observed in the study."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Cost-Effectiveness Analysis of Drug Therapies for Diabetes Mellitus Type 2 in Chile (ISPOR-EU 2022) - " The combination of empagliflozin/linagliptin had the highest QALYs (12.304 QALYs), while Liraglutide was the most expensive alternative with an accumulating cost of US$31,963. Glibenclamide/metformin was the most cost-effective alternative using a threshold of US$12,5000 per QALY, followed by Empagliflozin/Linagliptin, which was US$132,967 more expensive than glibenclamide, but also 0,177 QALYs more effective than glibenclamide."

HEOR • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus