metformin hydrochloride extended release / Generic mfg. - LARVOL DELTA

Impact of post approval quantitative changes in excipient composition on nitrosamine formation: De-risking strategy. (PubMed, Eur J Pharm Biopharm) - "In light of these recalls, we simulated the influence of post-approval level 1 and level 2 changes in excipient compositions on nitrosamine formation in metformin SR (sustained release) and losartan film coated tablets. Selecting formulation excipients with LNLs is critical for risk mitigation as was demonstrated in this study. To continue enjoying the regulatory flexibility in terms of reducing post approval variation submissions, it is paramount to assess the impact of nitrite load of excipients on the total nitrosamine burden of the product during product development."

Journal

At-line to in-line calibration transfer of a NIR PAT model via direct standardization for ribbon porosity monitoring in DoE-driven roller compaction of an extended-release formulation. (PubMed, Int J Pharm) - "This study combined a D-optimal design of experiments (DoE) to quantify the effects of roller-compaction process parameters on ribbon properties, downstream granule attributes, and extended-release metformin HCl/hydroxypropyl methylcellulose (HPMC) tablet properties, with near infrared/NIR-based process analytical technology/PAT-guided monitoring implemented via at-line models calibrated across the full DoE-generated porosity range (ε = 9.65-18.73%; DoE model R2 = 0.9365, Q2 = 0.9217). For porosity monitoring, at-line chemometric models were developed using baseline-oriented preprocessing, zero-order detrending (ZOD), two-point linear baseline correction (LBC), and asymmetric least-squares (AsLS) baseline correction, which provided robust predictions across the explored porosity range (root mean square error of prediction, RMSEP = 0.54-0.59%; R2 = 0.9671-0.9790). These models were successfully transferred to the in-line setting via direct standardization, reducing the..."

Journal

Metformin triggers apoptosis via endoplasmic reticulum stress in HER2-positive breast cancer cell lines. (PubMed, Exp Ther Med) - "Therefore, the present study aimed to investigate the dose-dependent effects of metformin on ER stress and apoptosis in HER2-positive breast cancer SKBR3 cells. The present findings demonstrated that metformin activates ER stress response and induces apoptosis in HER2-positive breast cancer cells in a dose-dependent manner. This supports the potential of metformin as an adjuvant therapy, though further in vivo studies are needed to evaluate its clinical applicability."

Journal • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ANXA5 • ATF6 • ERN1 • HER-2 • HSPA5 • PERK

Qiangji Decoction regulates AMPKα/Drp1/Nrf2 pathway to ameliorate neural damage induced by D-galactose by suppressing oxidative stress and neuronal apoptosis (PubMed, Zhongguo Zhong Yao Za Zhi) - "The Met group was administrated with metformin sustained-release tablets by gavage at a dose of 0.2 g·kg~(-1). Compared with the model group, the M-QJD, H-QJD, and Met groups showed improved learning and memory abilities, decreased neurons with shrinkage or deep staining and apoptotic neurons(P<0.05, P<0.01), downregulated expression of Bax, MDA, p-Drp1-Ser616/Drp1, and cleaved caspase-3/caspase-3 in the hippocampus(P<0.05, P<0.01), and upregulated expression of Bcl-2, T-SOD, GSH-PX, CAT, p-AMPKα-Thr172/AMPKα, Nrf2, HO-1, and NQO1 in the hippocampus(P<0.05, P<0.01). QJD could alleviate D-galactose-induced cognitive impairment, neuronal apoptosis, and oxidative stress by regulating the AMPKα/Drp1/Nrf2 pathway."

IO biomarker • Journal • Alzheimer's Disease • B Cell Lymphoma • CNS Disorders • Cognitive Disorders • Lymphoma • Oncology • BAX • CASP3 • CAT • HMOX1 • NQO1

Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion (clinicaltrials.gov) - P2 | N=26 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor

Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Wake Forest University Health Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Improving the effectiveness of ovarian stimulation by influencing carbohydrate metabolism (ISGE 2026) - "Women with HOMA-IR > 2 received low-dose extended-release metformin... Reharmonization protocol prior to IVF significantly enhances reproductive outcomes. Keywords: Insulin resistance; IGF-1; ovarian stimulation; in vitro fertilization; reharmonization; metformin; inositol; carbohydrate metabolism; reproductive endocrinology."

Endocrine Disorders • Gynecology • Metabolic Disorders • Polycystic Ovary Syndrome • IGF1

Title: Fetal Anomalies in Pregnancies Complicated by Pre-existing Type 2 Diabetes – A Case-based Review (ISGE 2026) - "Case: A 36-year-old woman with known T2D presented at 16 weeks' gestation on Janumet...Metformin XR 1 g bd was continued and basal insulin titrated up to 8 units, later adding 2 units rapid-acting insulin for post-lunch hyperglycaemia... Diabetic embryopathy is largely preventable. The presented case highlights that anomalies such as polydactyly may still occur when glycaemic control is achieved after organogenesis. Integrating pregnancy-intention screening and preconception optimisation into routine diabetes care is critical to reduce fetal malformation risk in women with type 2 diabetes."

Clinical • Review • Diabetes • Gestational Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • FOXO3

Efficacy and Safety of Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets in Chinese Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets (clinicaltrials.gov) - P=N/A | N=24 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Patterns and Clinical Outcomes of Sitagliptin/Metformin Extended-Release in Internal Medicine: A Real-World Multicenter Italian Study. (PubMed, J Clin Med) - " In this real-world internal medicine study, SITA/MET ER improved glycemic control and was well tolerated among patients with complex clinical profiles. These findings support the role of SITA/MET ER as a flexible and practical therapeutic choice in this setting."

Clinical data • Journal • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PCOS: Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome (clinicaltrials.gov) - P1 | N=116 | Recruiting | Sponsor: Jinnah Postgraduate Medical Centre

New P1 trial • Infertility • Metabolic Disorders • Polycystic Ovary Syndrome • Sexual Disorders

A multicenter, randomized, parallel-group clinical study on the effects of Henagliflozin Proline Tablets and Metformin Sustained-release tablets on body composition in geriatric patients with newly diagnosed type 2 diabetes mellitus (ChiCTR) - P=N/A | N=116 | Not yet recruiting | Sponsor: Huadong Hospital Affiliated to Fudan University; Huadong Hospital Affiliated to Fudan University

New trial • Diabetes • Geriatric Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

A randomized controlled trial study plan for metformin in the treatment of diabetic and non-diabetic periarthritis of the shoulder (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; Shanghai Guanghua Hospital of Integrated Traditional Chinese and We

New trial • Immunology

Natural polymers in diabetes management: formulation prospects of Hibiscus rosa-sinensis mucilage for metformin sustained release. (PubMed, Front Bioeng Biotechnol) - "Challenges of using mucilage include batch variability, microbial stability and limited clinical/non-clinical scientific data that indicated the need for the development of standardization and evaluation of its use. Future work includes the development of polymer."

Journal • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Northwestern University | Trial primary completion date: Dec 2025 ➔ Aug 2025

Trial primary completion date • Endometrial Cancer • Oncology • Solid Tumor

Comparative effectiveness of immediate-release and extended-release metformin on gastrointestinal tolerability, quality of life, and treatment satisfaction: A prospective cohort study. (PubMed, Medicine (Baltimore)) - "While the overall quality of life related to diabetes management improved similarly with both, the XR formulation reduced side effect burden, and the lower daily dosing led to higher patient-reported satisfaction. These findings support the use of metformin XR to enhance tolerability and adherence, potentially leading to improved long-term outcomes."

Clinical • HEOR • Journal • Observational data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase 2 study of letrozole, abemaciclib, and metformin in estrogen receptor (ER)–positive recurrent endometrial cancer (EC). (ASCO 2025) - P2 | "We conducted a phase 2 study of letrozole/abemaciclib/metformin in ER positive EC. Addition of metformin (at plasma concentrations sufficient to inhibit the PI3K pathway) to letrozole/abemaciclib is feasible and safe, and appears to induce deeper responses (including complete responses) and more prolonged PFS than letrozole/abemaciclib alone. NSMP tumors without RB1 and CCNE1 alterations derive the most benefit from this regimen."

P2 data • Endometrial Cancer • Fatigue • Neutropenia • Oncology • Solid Tumor • AMPK • CCNE1 • ER • IGF1 • PGR • POLE • RB1 • TP53

Efficacy of immediate-release versus extended-release metformin on glycemic control and insulin resistance in Saudi patients with type 2 diabetes: A prospective cohort study. (PubMed, J Taibah Univ Med Sci) - "In newly diagnosed Saudi patients with T2DM, metformin XR showed better reduction in long-term glycemic control compared to IR, while both formulations similarly reduced insulin levels and resistance. XR's enhanced glycemic efficacy, achieved without differences in insulin resistance effects, may reflect improved adherence and sustained drug delivery."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

SIGMA2MGH: Study of Clinical Response to Acute Metformin By Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS (clinicaltrials.gov) - P=N/A | N=1017 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HABIT-GEMs: Effects of Henagliflozin Proline and Metformin XR on Body Composition in Geriatric Patients With Newly Diagnosed T2DM (clinicaltrials.gov) - P4 | N=116 | Not yet recruiting | Sponsor: Bin Lu

New P4 trial • Diabetes • Geriatric Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

Met-PEFpilot: Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction (clinicaltrials.gov) - P2 | N=86 | Active, not recruiting | Sponsor: Wake Forest University Health Sciences | Trial completion date: Dec 2025 ➔ Apr 2026

Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Metformin and Nightly Fasting in Women With Early Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | N=37 ➔ 120

Enrollment change • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Public Health. (PubMed, Alzheimers Dement) - "MET-FINGER is the first trial combining a multimodal lifestyle intervention with a putative disease-modifying drug for the prevention of cognitive impairment. Its findings will provide crucial information for innovative precision-prevention strategies aimed at cognitive impairment and dementia risk-reduction, and evidence which will form the basis for a larger phase-III trial design and other future research."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Wake Forest University Health Sciences

New P2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor