metformin hydrochloride extended release / Generic mfg. - LARVOL DELTA

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

SMART: A Pilot Study of Metformin to Reduce Cerebrovascular Dysfunction in Participants With HIV and Metabolic Syndrome. (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: University of Stellenbosch | Recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • 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 primary completion date: Aug 2025 ➔ Mar 2026

Trial primary completion date • Metabolic Disorders • Oncology

Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia (clinicaltrials.gov) - P2 | N=34 | Active, not recruiting | Sponsor: University of Arizona | Trial completion date: Aug 2028 ➔ Dec 2026 | Trial primary completion date: Aug 2026 ➔ Dec 2025

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

GLP1R and OCT1 variants modulate semaglutide and metformin response in type 2 diabetes. (PubMed, Pharmacogenet Genomics) - "Semaglutide outperformed metformin for short-term weight loss. An HDL signal for OCT1 rs34130495 at an exploratory 10% FDR warrants replication. These hypothesis-generating data support the feasibility of genotype-guided studies in local clinical settings."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • SLC22A1

Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study (clinicaltrials.gov) - P4 | N=268 | Recruiting | Sponsor: Zhejiang Provincial People's Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

Biorelevant simulation of GI variability and its impact on the release behavior of non-disintegrating formulations: A case study using DHSI-IV (NERDT) system as a novel in vitro tool. (PubMed, Int J Pharm) - "This study employed the dynamic human stomach-intestine (DHSI-IV, branded as NERDT) system to characterize how gastric emptying kinetics and intestinal environmental dynamics affect drug release, using extended-release metformin matrix tablets (Glucophage XR®) and metformin osmotic pump tablets (Nida®) as model formulations...By integrating dynamic gastric and intestinal parameters, the DHSI-IV (NERDT) system addresses limitations of static models in capturing GI dynamics and predicting formulation-specific responses to GI variability, enabling more precise in vivo dissolution replication. This dynamic in vitro approach provides mechanistic insights into size-dependent release and motility-induced burst release, offering a novel strategy for data-driven optimization of solid drug formulations."

Journal • Preclinical

Adjuvant potential of metformin with standard anti-seizure medications in persons with active epilepsy: a randomised controlled trial. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This is a single-centric, double-blind, placebo-controlled trial randomised a-PWE (1:1) to receive either metformin (extended-release 500 mg) or matching placebo for 6 months along with background antiseizure medications. Metformin intervention at the selected dose was not effective in terms of seizure reduction or modulation of mTOR expression compared to placebo. Further studies with higher dose with longer duration of intervention may be needed to establish the findings. Trial registration no. CTRI/2023/10/058825, date: 18.10.2023."

Journal • CNS Disorders • Epilepsy • mTOR

Efficacy and safety of a novel oral small molecule GLP-1RA (HRS-7535) in Chinese patients with type 2 diabetes inadequately controlled by metformin and SGLT2 inhibitor (EASD 2025) - P2 | "During the lead in period, HRS-7535 placebo tablet and henagliflozin metformin extended-release tablets were administrated to pts. HRS-7535 achieved significant HbA1c reduction in Chinese pts with T2DM inadequately controlled on metformin and an SGLT2 inhibitor, and exhibited a safety profile consistent with other GLP-1RAs. These data support further clinical development of HRS-7535 for T2DM treatment."

Clinical • Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Jul 2025 ➔ Jul 2027

Trial completion date • Hematological Malignancies • Monoclonal Gammopathy • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma • IGH • SDC1

Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD (clinicaltrials.gov) - P2 | N=38 | Active, not recruiting | Sponsor: University of Florida | N=18 ➔ 38 | Trial completion date: Jun 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

Implementation of Metformin Therapy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): study protocol for a phase III, multi-centre, randomized, placebo-controlled trial evaluating the long-term efficacy of metformin in slowing the rate of kidney function decline in patients with autosomal dominant polycystic kidney disease. (PubMed, Trials) - P3 | "If proven effective, metformin would positively impact the well-being of people with ADPKD as a treatment option that is widely available and affordable."

Clinical protocol • Journal • P3 data • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Pain • Polycystic Kidney Disease • Renal Disease

Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Northwestern University | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometrial Cancer • Oncology • Solid Tumor

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

RESILIENCE: TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Myopharm Limited

New P2 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus