Glucophage

(Metformin)

ApprovedSmall molecule

Metformin is used to treat type 2 diabetes by helping your body control blood sugar levels. It works by reducing the amount of sugar your liver produces and helping your body use insulin more effectively.[2] Glucophage is currently approved and in use across 197 indications[4].[1]

Glucophage is one of 2692 small molecule programs targeting Obesity. It is currently in Approved.

197

Indications

1,440

Total Trials

Active Trials

2,691

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ObesityTerminated

Insulin ResistanceUnknown status

Gestational DiabetesWithdrawn

Atrial FibrillationCompleted

FibrosisActive, not recruiting

GlioblastomaActive, not recruiting

Acute Myeloid LeukemiaWithdrawn

Type 2 DiabetesCompleted

MelanomaTerminated

EncephalopathyActive, not recruiting

ObesityApproved

Terminated

Insulin ResistanceApproved

Unknown status

Gestational DiabetesApproved

Withdrawn

Atrial FibrillationApproved

Completed

FibrosisApproved

Active, not recruiting

GlioblastomaPhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Withdrawn

Type 2 DiabetesApproved

Completed

MelanomaPhase 2

Terminated

EncephalopathyApproved

Active, not recruiting

Showing 10 of 196 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Glucophage

EMD Serono

Approved

30 2

Lexiscan

Astellas

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Duragesic

CCephalon

Preclinical

1 6

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Rilvegostomig

AstraZeneca

Preclinical

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Tianeptine

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Type 2 Diabetes

NCT06972732

N/ANot yet recruiting

Osteoarthritis

NCT06328426

Q1 2027

N/ANot yet recruiting

Blood-Brain Barrier

NCT06965868

Q2 2027

N/ARecruiting

Obesity

NCT07293325

Q4 2027

Post-ApprovalNot yet recruiting

Prevention

NCT06682351

Post-ApprovalNot yet recruiting

Type 2 Diabetes

NCT07173712

Clinical

Trials by Indication[1]

Type 2 Diabetes45 trials

Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01318109·288 enrolled

Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes

Terminated· Incyte logo

Incyte·Phase 2·NCT00698789·48 enrolled

Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes

Completed·KKing Abdulaziz University·Phase 2·NCT01935804·440 enrolled

Show 42 more trials

Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

Unknown status·HHospital de Clinicas de Porto Alegre··NCT00935805·124 enrolled

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00331851·584 enrolled

Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Completed· Novartis logo

Novartis·Phase 3·NCT00728351·317 enrolled

Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

Completed·SShanghai Jiao Tong University School of Medicine·Phase 1/2·NCT00425009·70 enrolled

Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00915772·567 enrolled

Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes

Not yet recruiting·YYanbing Li·Phase 4·NCT07173712·324 enrolled

Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01006590·286 enrolled

Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)

Completed·WWellstat Therapeutics·Phase 2·NCT00110851·90 enrolled

Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT01123980·521 enrolled

Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

Terminated· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00469586·174 enrolled

Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00184574·603 enrolled

Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00598793·242 enrolled

A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes

Recruiting· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 4·NCT06972732·204 enrolled

Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 in Type 2 Diabetes Patients Taking Metformin

Completed· GSK logo

GSK·Phase 2·NCT01929863·16 enrolled

Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00328172·302 enrolled

Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

Completed·TTehran University of Medical Sciences·N/A·NCT01593371·98 enrolled

MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00482729·1,246 enrolled

Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT01720290·150 enrolled

Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh

Not yet recruiting·—·Phase 4·NCT06449235·938 enrolled

Effect of Metformin and Cholecystokinin-mediated Gallbladder Emptying on GLP-1 Secretion in Type 2 Diabetes

Completed·UUniversity Hospital, Gentofte, Copenhagen·N/A·NCT02497313·15 enrolled

Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients

Completed·LLaboratorios Silanes S.A. de C.V.·Phase 4·NCT01429818·16 enrolled

A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01217073·685 enrolled

Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

Completed· Sanofi logo

Sanofi·Phase 4·NCT02836704·892 enrolled

Impact of P53 and SIRT1 in Type 2 Diabetes

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT03925714·90 enrolled

Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00627445·441 enrolled

Polypill Versus Metformin in New Onset Type 2 Diabetes

Withdrawn·GGeorge Medicines PTY Limited·Phase 2·NCT05833958

Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes

Completed· Takeda logo

Takeda·Phase 4·NCT00754403·312 enrolled

GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Completed· Sanofi logo

Sanofi·Phase 3·NCT00712673·680 enrolled

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00856986·987 enrolled

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga

Completed·PPopulation Health Research Institute·Phase 4·NCT02561130·154 enrolled

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

Completed· GSK logo

GSK·Phase 3·NCT00359112·544 enrolled

Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes

Completed·AAzienda Ospedaliero-Universitaria di Parma·Phase 3·NCT01822548·64 enrolled

To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

Completed· GSK logo

GSK·Phase 2·NCT01725126·53 enrolled

Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01131182·1,147 enrolled

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT01519674·582 enrolled

Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 4·NCT02719132

Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

Completed· Sanofi logo

Sanofi·Phase 4·NCT03359837·384 enrolled

A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00672386·352 enrolled

A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00960661·1,036 enrolled

Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT00592969·164 enrolled

Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 2·NCT00614055·178 enrolled

Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT00619697·260 enrolled

Metformin22 trials

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00968812·1,452 enrolled

Effect of Genetic Variants in MATE1 and OCT3 on the Pharmacodynamics of Metformin in African Americans

Completed·UUniversity of California, San Francisco·Phase 1·NCT01681693·33 enrolled

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin

Completed· Astellas logo

Astellas·Phase 1·NCT01884558·24 enrolled

Show 19 more trials

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01365091·112 enrolled

Vaginal Administration of Metformin in PCOS Patients.

Unknown status·—·Phase 1·NCT02026869·200 enrolled

Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

Terminated· Pfizer logo

Pfizer·Phase 1·NCT00809536·24 enrolled

Effect of Metformin on Non PCO Women Undergoing IVF/ICSI

Completed·KKasr El Aini Hospital·N/A·NCT04489147·400 enrolled

Impact of OCT1 on Metformin Tolerance

Completed·NNHS Tayside·Phase 4·NCT02586636·61 enrolled

Metformin to Reduce Airway Glucose in COPD Patients

Completed·IImperial College London·Phase 2·NCT03651895·14 enrolled

Genomic Outcomes of Metformin

Completed·WWake Forest University Health Sciences·Phase 4·NCT02986659·30 enrolled

Limiting AAA With Metformin (LIMIT) Trial

Recruiting·SStanford University·Phase 2·NCT04500756·314 enrolled

Treating PCOS With Digital Intervention vs. Metformin

Completed·SShanghai 10th People's Hospital·N/A·NCT05386706·80 enrolled

A Trial of 2 Disease-Modifying Drugs (Metformin and N-acetylcysteine ) to Promote TB Lung Function Recovery

Not yet recruiting·OOpen Source Pharma Foundation·Phase 3·NCT07136987·1,104 enrolled

Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)

Completed·PPhilip Kern·Phase 1·NCT02308228·109 enrolled

Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects

Completed·GGeropharm·Phase 1·NCT03458208·18 enrolled

Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02221414·95 enrolled

Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT00819741·433 enrolled

The Copenhagen Insulin and Metformin Therapy Trial

Completed·SSteno Diabetes Center Copenhagen·Phase 4·NCT00657943·415 enrolled

Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02221180·2 enrolled

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00820573·16 enrolled

Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT01089179

Pioglitazone and Metformin in Diabetic Children

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 1/2·NCT01396564·56 enrolled

Type 2 Diabetes Mellitus14 trials

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01999218·1,326 enrolled

Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

Completed·RRodolfo Alejandro·Phase 1/2·NCT01786707·2 enrolled

Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01485614·200 enrolled

Show 11 more trials

A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

Completed· Sanofi logo

Sanofi·Phase 4·NCT02954692·112 enrolled

A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01958671·461 enrolled

A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00481663·555 enrolled

Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China

Completed·RRenJi Hospital·Phase 4·NCT02040246·107 enrolled

A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Completed· Astellas logo

Astellas·Phase 2·NCT01071850·412 enrolled

Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

Terminated· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00571519·94 enrolled

Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01368081·1,162 enrolled

ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

Completed· Sanofi logo

Sanofi·Phase 3·NCT00272064·352 enrolled

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Completed· Sanofi logo

Sanofi·Phase 3·NCT01169779·391 enrolled

PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy

Completed·—··NCT03155087·750 enrolled

Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

Unknown status·—··NCT04194515·50 enrolled

Polycystic Ovary Syndrome6 trials

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT02187250·45 enrolled

Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

Completed·UUniversity of Rochester·Phase 3·NCT00283816·36 enrolled

Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)

Completed·OOregon Health and Science University·N/A·NCT00694759·37 enrolled

Show 3 more trials

Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00005654·88 enrolled

Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT01911468·36 enrolled

Vitamin D for Polycystic Ovary Syndrome Clomiphene Resistant Women

Completed·—·Phase 4·NCT04010942·120 enrolled

Gestational Diabetes6 trials

Metformin and Sitagliptin in Women With Previous Gestational Diabetes

Completed·UUniversity of Pisa·Phase 2·NCT01336322·40 enrolled

Preventing Recurrent Gestational Diabetes With Metformin

Unknown status·IImperial College London·Phase 4·NCT02394158·112 enrolled

Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country

Unknown status·—·Phase 2/3·NCT01855763·300 enrolled

Show 3 more trials

Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus

Terminated·WWomen and Infants Hospital of Rhode Island·Phase 3·NCT03651531·1 enrolled

Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

Unknown status·MMaasstad Hospital·Phase 3·NCT02275845·400 enrolled

Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus

Active, not recruiting·KKing's College London·Phase 4·NCT04407650·64 enrolled

74 more indications

PreDiabetes4 trials

Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes

Completed·UUniversidad de Guanajuato·Phase 4·NCT03004612·144 enrolled

Metformin and Its Impact on the Substances Associated With NO Production in Prediabetes Patients.

Completed·WWroclaw Medical University·Phase 4·NCT03398356·47 enrolled

The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

Completed·SSt. Paul Heart Clinic·Phase 4·NCT00546728·50 enrolled

Show 1 more trial

Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin

Completed·—·Phase 2·NCT02552355·56 enrolled

Interaction4 trials

The Interaction Between Metformin and Microbiota - the MEMO Study.

Unknown status·UUmeå University··NCT03718715·600 enrolled

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

Completed·LLG Life Sciences·Phase 1·NCT01426399·30 enrolled

Drug Interaction With Metformin

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00546741·18 enrolled

Show 1 more trial

Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06071442·60 enrolled

Obesity3 trials

Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity

Completed·HHÜMEYRA ACIKAN·Phase 4·NCT06266598·52 enrolled

Use of Metformin in Treatment of Childhood Obesity

Completed·UUniversity of Colombo·Phase 4·NCT02274948·339 enrolled

Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT07293325·66 enrolled

Insulin resistance3 trials

Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder

Completed·CCynthia Calkin·Phase 3·NCT02519543·50 enrolled

Physical Inactivity and Insulin Resistance in Skeletal Muscle.

Withdrawn·UUniversity of Kansas Medical Center·N/A·NCT00536211

Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study

Withdrawn·UUniversity of Minnesota·Phase 4·NCT00775164

Type 2 Diabetic Patients3 trials

Insulin Glulisine in Type 2 Diabetic Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00360698·106 enrolled

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

Completed· Roche logo

Roche·Phase 3·NCT00755287·1,072 enrolled

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT02338921·78 enrolled

Empagliflozin3 trials

The Effects of Empagliflozin on Arterial Wall Characteristics

Unknown status·UUniversity Medical Centre Ljubljana·Phase 4·NCT03639545·120 enrolled

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02230995·30 enrolled

Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes

Unknown status·UUniversidad de Guanajuato·Phase 3·NCT04131582·34 enrolled

Endometrial Cancer3 trials

Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01911247·28 enrolled

Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients

Completed·HHospices Civils de Lyon·Phase 1/2·NCT02755844·35 enrolled

Clinical Effects of Metformin on Fertility-sparing Treatment for Early Endometrial Cancer

Unknown status·SSamsung Medical Center·Phase 3·NCT04792749·77 enrolled

Schizophrenia3 trials

Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics

Completed·—·Phase 4·NCT05663749·60 enrolled

Comparison of Berberine and Metformin for the Treatment for MS in Schizophrenia Patients

Unknown status·TTianjin Anding Hospital·Phase 4·NCT03708549·100 enrolled

MEtformin and Lorcaserin for WeighT Loss in Schizophrenia

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT02796144·71 enrolled

Monotherapy2 trials

Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

Completed· Novo Nordisk logo

Novo Nordisk··NCT00745433·906 enrolled

Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM

Completed·WWoman's·Phase 4·NCT01856907·36 enrolled

Pregnancy2 trials

Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Completed·—·Phase 2·NCT02562664·66 enrolled

The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic, Chronic Oligoovulatory or Anovulatory Women

Completed·559th Medical Wing·Phase 3·NCT00413179·56 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

Completed·—·Phase 1/2·NCT02949700·26 enrolled

Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

Completed·UUniversity of Cincinnati·Phase 1·NCT02325401·20 enrolled

Type 1 Diabetes2 trials

A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes

Completed·—·Phase 4·NCT01718093·21 enrolled

Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes

Completed·UUniversity of Colorado, Denver·Phase 4·NCT01813929·23 enrolled

Prevention2 trials

Metformin for the Prevention of the Metabolic Side-effects of Zyprexa

Completed·RRush University Medical Center·Phase 4·NCT00682448·25 enrolled

Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention

Not yet recruiting·SStanford University·Phase 4·NCT06682351·200 enrolled

Metastatic Prostate Cancer2 trials

Metformin Hydrochloride as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

Completed·SSwiss Cancer Institute·Phase 2·NCT01243385·44 enrolled

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Active, not recruiting·MMedical Research Council·Phase 2/3·NCT00268476·11,992 enrolled

Diabetes2 trials

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

Completed· GSK logo

GSK·Phase 3·NCT00379769·4,447 enrolled

A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02152371·300 enrolled

Diabetes Mellitus2 trials

Metformin as Adjuvant to Insulin Therapy in Insulin-resistant Diabetes Mellitus With Pregnancy

Completed·—·Phase 3·NCT01915550·90 enrolled

Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

Unknown status· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 3·NCT02477969·587 enrolled

Prostate Cancer2 trials

Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT01620593·41 enrolled

The Effect of Metformin in Patients With Metastatic Castration-resistant Prostate Cancer

Unknown status·SSun Yat-sen University·Phase 2·NCT04926155·234 enrolled

Heart Failure2 trials

Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure

Completed·—·Phase 2·NCT02810132·36 enrolled

Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction

Active, not recruiting·WWake Forest University Health Sciences·Phase 2·NCT05093959·86 enrolled

Double-blind2 trials

A Double-Blind, Placebo-Controlled Trial of Anti-Aging, Pro-Autophagy Effects of Metformin in Adults With Prediabetes

Completed·UUniversity of New Mexico·Phase 3·NCT03309007·25 enrolled

Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

Completed·PPhaseBio Pharmaceuticals Inc.·Phase 2·NCT01658501·593 enrolled

SGLT2 Inhibitors2 trials

SGLT2 Inhibitors in Treating Patients With PCOS

Enrolling by invitation·SShanghai 10th People's Hospital·N/A·NCT05966792·80 enrolled

SGLT2 Inhibitors in Patients With PCOS

Completed·SShanghai 10th People's Hospital·Phase 4·NCT04700839·68 enrolled

Coronary Artery Disease2 trials

Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT00513630·304 enrolled

Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus

Completed·UUniversity of Athens·N/A·NCT03010683·60 enrolled

Obese Children and Adolescents2 trials

Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Completed·—·N/A·NCT05572749·75 enrolled

Metformin in Obese Children and Adolescents

Completed·SSt. Antonius Hospital·Phase 3·NCT01487993·62 enrolled

Endothelial Function1 trial

Effects of Lipemia and Metformin on Endothelial Function

Completed·—·Phase 1·NCT01037660·139 enrolled

Fasting Conditions1 trial

A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 1·NCT02088918·40 enrolled

Function1 trial

Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

Unknown status·Xxiaolong zhao·Phase 4·NCT02129985·100 enrolled

Sepsis1 trial

Metformin and Lactoferrin in Sepsis in Icu

Recruiting·TTanta University·Phase 2/3·NCT06181422·60 enrolled

Insulin Resistant1 trial

Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial)

Completed·UUniversity of Dundee·Phase 4·NCT00473876·62 enrolled

Overweight or Obese1 trial

A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05815680·48 enrolled

Coronary Artery Bypass1 trial

Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients

Completed·EEmory University·Phase 3·NCT01792830·175 enrolled

Osteoarthritis1 trial

Vitamin D With Omega-3 or Metformin in Osteoarthritis

Not yet recruiting·—·N/A·NCT06328426·60 enrolled

Overweight1 trial

Comparing the Effect of Metformin vs. Pep2dia as an Adjunct to Letrozole on Ovulation Induction and Pregnancy Outcomes in Overweight Women With PCOS

Completed·MMuhamed Ahmed Abdelmoaty Muhamed Alhagrasy·Phase 1·NCT06452511·100 enrolled

Cardiovascular1 trial

Metformin And Cardiovascular Effectiveness vs SGLT2 (MACES)

Unknown status·—··NCT03627039·20,000 enrolled

Treatment1 trial

Diabetic Treatment Adherence

Completed·MM.D. Anderson Cancer Center··NCT01318564·28 enrolled

Safety and Efficacy1 trial

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00401973·199 enrolled

Chronic Periodontitis1 trial

Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

Completed·GGovernment Dental College and Research Institute, Bangalore·Phase 2/3·NCT03204071·90 enrolled

Atrial Fibrillation1 trial

METFORMIN FOR ATRIAL FIBRILLATION

Unknown status·—·Phase 2·NCT05878535·770 enrolled

Type 1 Diabetes Mellitus1 trial

Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment

Unknown status·HHellenic Institute for the Study of Sepsis·Phase 3·NCT04177303·44 enrolled

Polycystic Ovarian Syndrome1 trial

Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome

Completed·—·N/A·NCT01679574·200 enrolled

Metabolic Syndrome1 trial

Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome

Completed·RRutgers University·Phase 2/3·NCT03355469·91 enrolled

GLP-11 trial

Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion

Completed·—·Phase 1·NCT02749032·24 enrolled

Wound Healing1 trial

Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT01666665·36 enrolled

Locally-advanced Rectal Cancer1 trial

Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer (METCAP).

Completed·CCentre Oscar Lambret·Phase 2·NCT02437656·60 enrolled

Glaucoma1 trial

Metformin as a Neuroprotective Therapy for Glaucoma

Recruiting·CChristopher Kai Shun Leung·Phase 2·NCT05426044·125 enrolled

Spinal Cord Injury1 trial

Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury

Not yet recruiting·—·Phase 4·NCT07272967·34 enrolled

Ulcerative Colitis1 trial

Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Completed·TTanta University·Phase 2·NCT05553704·60 enrolled

Atherosclerotic Plaque1 trial

Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

Completed·—·N/A·NCT00636766·300 enrolled

Breast Cancer1 trial

Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

Completed·UUniversity of California, San Diego·N/A·NCT01302379·333 enrolled

Weight Gain1 trial

Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT00617240·9 enrolled

Hypogonadism1 trial

Testosterone, Metformin, or Both, for Hypogonadism in Obese Males

Completed·FFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·Phase 3·NCT02514629·107 enrolled

Blood-Brain Barrier1 trial

Role of the Blood-Brain Barrier in Stress Resilience: Investigating New Pathways Towards Pharmacological Augmentation of Stress Resilience

Not yet recruiting·LLeibniz-Institut für Resilienzforschung (LIR) gGmbH·N/A·NCT06965868·122 enrolled

Prospective1 trial

Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

Unknown status·PPoznan University of Medical Sciences·N/A·NCT00396513

In Vitro Fertilization (IVF)1 trial

Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

Completed·UUniversity of Oxford·N/A·NCT01046032·134 enrolled

Older People1 trial

DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study)

Withdrawn·DDiabetes Frail Ltd·Phase 3·NCT02484209

Liraglutide1 trial

Liraglutide Treatment in Obese Infertile PCOS Women

Recruiting·PPeking University Third Hospital·Phase 4·NCT06742710·890 enrolled

Observational Study1 trial

An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

Completed· Merck & Co. logo

Merck & Co.··NCT01357135·3,453 enrolled

Hyperglycemia1 trial

ß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT01717911·160 enrolled

COVID-191 trial

Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

Withdrawn·AAgelessRx·Phase 2·NCT04604678

Spironolactone1 trial

Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS

Completed·SShiraz University of Medical Sciences·Phase 1·NCT02689843·90 enrolled

Nephrogenic Diabetes Insipidus1 trial

Metformin and Congenital Nephrogenic Diabetes Insipidus

Terminated·EEmory University·Phase 1·NCT02460354·2 enrolled

Cardiovascular Disease1 trial

Clinical Outcomes and Healthcare Cost and Resource Utilization (HCRU) in Patients With Type 2 Diabetes and Cardiovascular Disease on 2nd Line Empagliflozin Versus 2nd Line Sulfonylureas

Withdrawn· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05102071

Obese Patients1 trial

Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes

Completed·SSteno Diabetes Center Copenhagen·Phase 4·NCT00118963·102 enrolled

Phase 11 trial

Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers

Completed·AAnne Chang·Phase 1·NCT03072485·10 enrolled

Chronic Kidney Disease1 trial

Comparative Effectiveness of Metformin for Type 2 Diabetes With Chronic Kidney Disease

Completed·WWeill Medical College of Cornell University··NCT03921242·4,888 enrolled

Non-Small Cell Lung Carcinoma1 trial

Metformin Plus TKI Use in Patients With Non-Small Cell Lung Carcinoma

Unknown status·IInstituto Nacional de Cancerologia de Mexico·N/A·NCT03071705·120 enrolled

PCOS1 trial

Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Completed·RRenJi Hospital·N/A·NCT02446834·40 enrolled

Metabolism1 trial

Effect of Metformin on Lactate Metabolism

Completed·CCentre de Recherche en Nutrition Humaine Rhone-Alpe·Phase 1/2·NCT00390273·20 enrolled

Antipsychotics1 trial

Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics

Unknown status·—·Phase 4·NCT00845936·30 enrolled

Arthritis1 trial

The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

Completed·MMenoufia University·N/A·NCT05332795·100 enrolled

Papillary Renal Cell Carcinoma1 trial

Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT02495103·7 enrolled

Assisted Reproductive Technology1 trial

The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows

Unknown status·TThe Baruch Padeh Medical Center, Poriya·Phase 2·NCT02848950·100 enrolled

Hyperplasia1 trial

Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

Completed·KKayseri Education and Research Hospital·Phase 4·NCT02872818·40 enrolled

TED1 trial

Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis

Completed·—·Phase 2/3·NCT00683735·20 enrolled

Infertility1 trial

Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility

Unknown status·EElham Raafat·Phase 1·NCT03681197·170 enrolled

Unspecified2 trials

New Approaches to INOCA

Completed·PPasquale Mone··NCT05740345·3,000 enrolled

Renal and Hormonal Effects of Pioglitazone

Completed·UUniversity Hospital, Geneva·Phase 4·NCT01090752·16 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 5, 1998

GLUCOPHAGE

NDA NDA020357

Oct 13, 2000

GLUCOPHAGE XR

NDA NDA021202

Sep 11, 2003

RIOMET

NDA NDA021591

Apr 27, 2004

FORTAMET

NDA NDA021574

Jun 3, 2005

GLUMETZA

NDA NDA021748

Aug 29, 2019

RIOMET ER

NDA NDA212595

Sources

References

[1]
ClinicalTrials.gov — 1440 trial records for Metformin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Glucophage drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Metformin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Metformin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212595). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Glucophage. U.S. Food & Drug Administration.
[7]
SEC EDGAR — EMD Serono company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mitochondrial Complex I (NADH Dehydrogenase) Inhibitor; Mitochondrial Glycerol-3-Phosphate Dehydrogenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EMD Serono

Patent Landscape[6]

Patent Cliff

May 1, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9962336May 1, 2035