metformin hydrochloride extended release / Generic mfg. - LARVOL DELTA

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

A Comparative Analysis of Efficacy, Medication Adherence and Safety Between Henagliflozin Proline, Retagliptin Phosphate and Metformin Hydrochloride Sustained-release Tablets and Triple Antidiabetic Regimen in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control after Dual Oral Therapy (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

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

The Effect of Metformin in Patients With Newly Diagnosed mHSPC (clinicaltrials.gov) - P2 | N=266 | Active, not recruiting | Sponsor: Sun Yat-sen University | Trial completion date: Aug 2027 ➔ Jan 2027 | Trial primary completion date: Apr 2027 ➔ Aug 2026 | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Managing Chronic Tendon Pain by Metformin (clinicaltrials.gov) - P1 | N=21 | Terminated | Sponsor: James Wang | N=40 ➔ 21 | Recruiting ➔ Terminated; The study funding has ended.

Enrollment change • Trial termination • Musculoskeletal Pain • Pain

Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: University of Florida | Trial completion date: Jun 2026 ➔ Aug 2027

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

Metformin hydrochloride extended-release tablets: perception of the occurrence of gastrointestinal adverse events and biopharmaceutical evaluation. (PubMed, An Acad Bras Cienc) - "Our findings reinforce the interchangeability between reference and generic medicines, providing an effective option for patients with type II diabetes mellitus. This strengthens the principles of the National Generic Medicines Policy in Brazil, contributing to the sustainability of the healthcare system and the democratization of access to essential medicines."

Adverse events • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hyperemesis Gravidarum Risk Reduction With Metformin (clinicaltrials.gov) - P1/2 | N=224 | Recruiting | Sponsor: University of Southern California | Not yet recruiting ➔ Recruiting | Phase classification: P2 ➔ P1/2 | Initiation date: Jan 2026 ➔ Jul 2026 | Trial primary completion date: Jan 2030 ➔ Mar 2031

Enrollment open • Phase classification • Trial initiation date • Trial primary completion date • Rare Diseases

METDEXA-MM: Clinical Activity of Metformin With High-dose of Dexamethasone in Relapse Multiple Myeloma (clinicaltrials.gov) - P2 | N=28 | Terminated | Sponsor: University of Campinas, Brazil | Unknown status ➔ Terminated; Recruitment difficulties due to more attractive competing studies.

Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Evaluation of Superiority of Valsartan+Celecoxib+Metformin Over Metformin Alone in Type 2 Diabetes Patients (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: ARKAY Therapeutics | N=115 ➔ 0 | Trial completion date: Jan 2029 ➔ Jan 2031 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Nov 2028 ➔ Dec 2030

Enrollment change • Head-to-Head • Trial completion date • Trial primary completion date • Trial withdrawal • Cardiovascular • Diabetes • Genetic Disorders • Hypertension • Immunology • Metabolic Disorders • Obesity • Rheumatology • Type 2 Diabetes Mellitus • LEP

Plasma metformin concentration as a determinant of metabolic response in adults with type 1 diabetes: a 1-year prospective observational study. (PubMed, Front Pharmacol) - "This single-center, observational study included 26 adults with T1DM treated with extended-release metformin (500-2000 mg/day). Adjunctive metformin therapy in adults with T1DM was associated with favorable changes in insulin sensitivity markers and cardiometabolic risk parameters during follow-up. Monitoring metformin plasma concentrations and eGDR may provide complementary information for metabolic assessment during adjunctive metformin therapy in adults with T1DM."

Journal • Observational data • Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus

RESILIENCE: TriGlytza-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Myopharm Limited | N=90 ➔ 48 | Trial completion date: Jun 2028 ➔ Dec 2027 | Initiation date: Feb 2026 ➔ Sep 2026 | Trial primary completion date: Dec 2027 ➔ Sep 2027

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

Bioequivalence Study of Sitagliptin/Metformin Extended-Release Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: The Affiliated Hospital of Qingdao University

New P1 trial

Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Dan Zandberg | Trial completion date: Oct 2027 ➔ Apr 2032 | Trial primary completion date: Aug 2025 ➔ Apr 2032

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

A Phase 2 Feasibility Study Combining Pembrolizumab and Metformin in patients with Metastatic Head and Neck Cancer. (PubMed, Clin Cancer Res) - P2 | "The combination of metformin and pembrolizumab was well tolerated with mild GI-associated AEs and promising activity warranting further investigation in a randomized trial."

Journal • P2 data • Fatigue • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • PD-1

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

Trial completion • Infertility • Metabolic Disorders • Polyendocrine Metabolic Ovarian Syndrome • Sexual Disorders

NAE-PCOS: Effect of NAE on Polycystic Ovarian Syndrome (PCOS) (clinicaltrials.gov) - P1 | N=116 | Completed | Sponsor: Jinnah Sindh Medical University | Active, not recruiting ➔ Completed

Trial completion • Infertility • Metabolic Disorders • Polyendocrine Metabolic Ovarian Syndrome • Sexual Disorders

Application of Quality by Design (QbD) as Artificial Intelligence in Formulation for Diabetes: A Practical Review. (PubMed, Recent Adv Drug Deliv Formul) - "Although challenges exist with data integrity, regulatory interpretation, and the necessity for a combination of scientific themes, the AI-QbD framework is a transformational journey toward intelligent, patient-focused drug design. Future directions include advances like real-time release testing (RTRT), AI-enabled personalized medicine, and the integration with digital health."

Journal • Diabetes • Metabolic Disorders

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: City of Hope Medical Center | N=200 ➔ 80

Enrollment change • Breast Cancer • Oncology • Solid Tumor

Interim Analysis of Microbiome Remodeling Effects of Adjunct Therapy with Polyherbal Formulation (PHF) in Type 2 Diabetes Patients (ADA 2026) - "We assessed whether a standardized multi-extract polyherbal formulation (PHF) modulates gut microbiome composition and functional pathways when co-administered with maximally tolerated metformin XR. Adults with metformin intolerance (N=27) were randomized 1:1 to PHF+metformin XR or placebo+metformin XR for 7 days in an ongoing randomized, placebo-controlled trial... This interim analysis of a 7-day intervention phase indicates that PHF co-administered with metformin can rapidly and selectively remodel the gut microbiome in metformin-intolerant T2D. Although glycemic metrics were unchanged over this short period, compositional and functional shifts—particularly Bifidobacterium enrichment—support further evaluation of PHF to enhance metformin tolerability and potential longer-term efficacy."

Clinical • Late-breaking abstract • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • SLC22A1

Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo (clinicaltrials.gov) - P4 | N=150 | Active, not recruiting | Sponsor: University of California, Los Angeles | Trial completion date: Jul 2027 ➔ Jul 2028 | Trial primary completion date: Jul 2027 ➔ Oct 2027

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

NAE-PCOS: Effect of NAE on Polycystic Ovarian Syndrome (PCOS) (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Jinnah Sindh Medical University | Recruiting ➔ Active, not recruiting

Enrollment closed • Infertility • Metabolic Disorders • Polyendocrine Metabolic Ovarian Syndrome • Sexual Disorders

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

Trial primary completion date • Musculoskeletal Pain • Pain

NAE-PCOS: Effect of NAE on Polycystic Ovarian Syndrome (PCOS) (clinicaltrials.gov) - P1 | N=116 | Recruiting | Sponsor: Jinnah Sindh Medical University

New P1 trial • Infertility • Metabolic Disorders • Polyendocrine Metabolic Ovarian Syndrome • Sexual Disorders

Multidisciplinary approach with bariatric surgery, medication and nutritional regimen of patient with a BMI grater than 75 kg/m2 case report (ECO 2026) - "Pharmacologically, three months after surgery, treatment was started with a stepped dose ofsemaglutide (0.25 mg, 0.50 mg, and 1.00 mg), extended-release metformin (1000 mg), and tegoprazan (50 mg), and supplementation was continued. Regular exercise was incorporated into the patient's routine, and from a psychological perspective, information was provided on the importance of healthy sleep patterns, strategies for managing cravings, and emotional regulation. Efforts were made to promote family involvement in the change process."

Bariatric surgery • Case report • Clinical • Surgery • Gastrointestinal Disorder

UCCC-HN-19-01: Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Trisha Wise-Draper | Trial completion date: Dec 2025 ➔ Sep 2026

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