metformin hydrochloride extended release / Generic mfg. - LARVOL DELTA

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

UCCC-HN-19-01: Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Trisha Wise-Draper | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Hyperemesis Gravidarum Risk Reduction With Metformin (clinicaltrials.gov) - P2 | N=224 | Not yet recruiting | Sponsor: University of Southern California | Trial completion date: Oct 2030 ➔ Jan 2031 | Initiation date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2029 ➔ Jan 2030

Trial completion date • Trial initiation date • Trial primary completion date • Rare Diseases

Letrozole, abemaciclib and metformin in endometrial cancer: a non-randomized phase 2 trial. (PubMed, Nat Commun) - P2 | "Based on preclinical studies showing synergism with simultaneous inhibition of the estrogen receptor (ER), CDK4/6 and PI3K pathways and based on window of opportunity studies showing that metformin suppresses PI3K/mTOR signaling in endometrial cancer (EC), we conduct a non-randomized phase 2 study of letrozole/abemaciclib/metformin in ER positive endometrioid EC (NCT03675893). There are no objective responses among TP53 mutated ECs and among NSMP (no specific molecular profile) tumors with RB1 or CCNE1 alterations; CTNNB1 mutations correlate with clinical benefit. Pharmacokinetic analyses demonstrate that administration of letrozole and abemaciclib with metformin result in a more than 3-fold increase in metformin exposure."

Journal • P2 data • Endometrial Cancer • Oncology • Solid Tumor • CCNE1 • CDK4 • CTNNB1 • ER • RB1 • TP53

VA-IMPACT: Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (clinicaltrials.gov) - P4 | N=7410 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Mar 2029 ➔ Sep 2029 | Trial primary completion date: Mar 2029 ➔ Sep 2029

Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Metabolic Disorders

Managing Chronic Tendon Pain by Metformin (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: James Wang | Trial completion date: Oct 2025 ➔ Aug 2026 | Trial primary completion date: Oct 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

Metformin and Nightly Fasting in Women With Early Breast Cancer (clinicaltrials.gov) - P2 | N=37 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | N=120 ➔ 37 | Trial completion date: Nov 2025 ➔ Dec 2026

Enrollment change • Enrollment closed • Trial completion date • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Clinical and Economic Benefits of Extended-Release Metformin In Prediabetes Management (ISPOR-EU 2025) - "Routine XR metformin use in prediabetes lowers risks of T2D, CVD, and death, while reducing overall public healthcare costs despite modest individual spending."

Clinical • HEOR • Cardiovascular • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus

Bioequivalence and Pharmacokinetic Prediction of Oral Marketed Metformin Extended-Release Tablets in Saudi Arabia. (PubMed, Drug Dev Ind Pharm) - "The convolution approach indicated that Glucophage® and Formit® have bioequivalent Cmax of 601 and 592 ng/ml, respectively. The two products had the same projected Tmax of 2.0 hours and a modest AUC∞ differential that did not violate the FDA's 80-125% limit."

Journal • PK/PD data • Diabetes • Metabolic Disorders

An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer (clinicaltrials.gov) - P2 | N=96 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Trial completion date: Nov 2026 ➔ Mar 2027

Trial completion date • Metabolic Disorders • Oncology

Antidiabetic drug utilization pattern, affordability and cost analysis in Iran from 2009 to 2021: A need to revise guideline. (PubMed, PLoS One) - "Most novel non-insulin antidiabetic products such as empagloflozin, sitagliptin and extended-release metformin were unaffordable during the study period. The number of unaffordable medicines increased during the study due to the introduction of some novel antidiabetic drugs. Therefore, it is important to revise the diabetes guidelines to promote rational drug use."

HEOR • Journal • Retrospective data • Diabetes • Metabolic Disorders

Effect of bromocriptine mesylate on the patients of polycystic ovary syndrome (ChiCTR) - P4 | N=120 | Recruiting | Sponsor: Sir Run Run Hospital, Nanjing Medical University; Sir Run Run Hospital, Nanjing Medical University

New P4 trial • Polycystic Ovary Syndrome • HP

Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Northwestern University | Recruiting ➔ Active, not recruiting | N=75 ➔ 50

Enrollment change • Enrollment closed • IO biomarker • Lung Cancer • Obesity • Oncology • Ovarian Cancer • Solid Tumor