Change in C-Reactive Protein [ Time Frame: 10 days ], Change in Albumin [ Time Frame: 10 days ], Change in Viral load [ Time Frame: 10 days ], Emergency Department Utilization [ Time Frame: 14 days, 28 days ], Incidence of Possible COVID-19 Symptoms [ Time Frame: 14 days, 28 days ], WHO Disease Progression Scale [ Time Frame: 14 days, 28 days. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Outcome is reported as the change in serum concentrations of c-reactive protein (mg/L) from baseline to 5 days and baseline to 10 days. Clinical trials are research studies that involve people. Researchers think that metformin may reduce the risk of getting prostate cancer or may even be able to treat it. Metformin hydrochloride may reduce the metabolic activity of cancer cell and of surrounding supportive tissues. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. The discovery of metformin began with the synthesis of galegine-like compounds derived from Gallega officinalis, a plant traditionally employed in Europe as a drug for diabetes treatment for centuries [].In 1950, Stern et al. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 can improve laboratory outcomes associated with Covid-19 severity. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Location: 3 locations, This early phase I trial studies how well metformin hydrochloride works when added to levonorgestrel-releasing intrauterine system in treating patients with atypical endometrial hyperplasia or endometrial cancer who cannot undergo surgery. Metformin has about 24 times less reported incidents of lactic acidosis compared with phenformin. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells. The TAME (Targeting Aging with Metformin) Trial will establish a clinical trial to provide proof-of-concept that aging can be treated, just as we treat diseases. While vaccine development for SARS-CoV-2 has been promising, there may be reduced willingness among the public to receive a vaccine developed so quickly. A listing of Diabetes Mellitus Type 2 medical research trials actively recruiting patient volunteers. Urbana, Ill. (WCIA) Dr. Arnon Gal, veterinarian with the internal medicine service at the University of Illinois Veterinary Teaching Hospital, shares details on an exciting new clinical trial that is open to dogs and cats in our viewing area that have diabetes. Electronic medical record history of kidney disease, i.e. ], Incidence of hospitalization for Covid-19. Location: 20 locations, This randomized phase II trial studies how well chemotherapy with or without metformin hydrochloride work in treating patients with HER2 positive breast cancer that can be removed by surgery. Dr. These studies provide important information to advance medical research and are crucial to developing a cure for diabetes. This ground breaking clinical trial, called Targeting Aging with Metformin (TAME) will test whether metformin can delay the onset of age-related diseases and conditions including cancer, cardiovascular disease and Alzheimer’s disease. GlobalData analysed the number of clinical trials examining the drug metformin hydrochloride with start dates between 1 January 2009 and 17 September 2019. Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, This phase II pilot trial studies how will metformin hydrochloride works in mitigating the side effects of radioactive iodine treatment in patients with differentiated thyroid cancer. This is one of the primary outcomes for the stage 1 trial. Bramante et al. Metformin was most effective in women with a history of gestational diabetes, in people between the ages of 25 and 44, and in people with obesity who had a body mass index of 35 or higher. Other companies, including San Francisco-based Enlibrium, also have plans to evaluate metformin derivatives for use in oncology. What clinical trials for diabetes are open? You may want to think about taking part in a clinical trial. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 2020 Jul;583(7816):459-468. doi: 10.1038/s41586-020-2286-9. DPP Study Design. The fully powered trial is a parallel enrolling treatment and post-exposure prophylaxis trial. The study will evaluate 3,000 people over a course of six years. Estrogen may cause cancer. Choosing to participate in a study is an important personal decision. Chemoprevention is the use of certain drugs to keep cancer from forming. Location: 14 locations, This early phase I trial studies the effects of metformin hydrochloride in participants with malignant solid tumors. Study record managers: refer to the Data Element Definitions if submitting registration or results information. While anti-viral activity may be contributing to the observational associations of reduced severity of Covid-19, metformin has a proven history of beneficial immune-modulatory effects, including on CRP, IL-6 and TNF-alpha, neutrophil extracellular traps, and improved T cell immunity. Metformin suppresses colorectal aberrant crypt foci in a short-term clinical trial. The DPP was a randomized, controlled clinical trial conducted at 27 clinical centers around the United States from 1996 to 2001. Giving metformin hydrochloride in addition to treatment with levonorgestrel-releasing intrauterine system may be an effective alternative for patients with atypical endometrial hyperplasia or endometrial cancer who cannot undergo surgery. In contrast, clinical trials of metformin in pancreatic cancer did not show a survival benefit . Since September 27, 2007, results of Lilly clinical trials have been presented on clinicaltrials.gov for compounds that are approved for use in humans. Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), MET-COVID Trial - Metformin for Outpatient Treatment and Post-exposure Prophylaxis (PEP) of COVID-19, Experimental: PEP Cohort - Treatment Group, Placebo Comparator: PEP Cohort - Placebo Group, Experimental: Treatment Arm - Treatment Group, Placebo Comparator: Treatment Arm - Placebo Group, 30 Years to 85 Years   (Adult, Older Adult), Minneapolis, Minnesota, United States, 55455. Information provided by (Responsible Party): Participants in the PEP cohort of the trial are those who do not test positive for SARS-COV-2 infection at the time of screening but had a close exposure to SARS-CoV-2 infected person (defined by current CDC definition of close contact). Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors learn more about the effects of metformin hydrochloride on cells. Nelfinavir and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Symptom onset greater than 7 days before randomization (symptoms not required for inclusion). Location: Mayo Clinic in Rochester, Rochester, Minnesota, This phase II trial studies how well metformin hydrochloride works together with doxycycline in treating patients with localized breast, uterine, or cervical cancer. Location: 6 locations, This phase I / II trial studies the side effects and best dose of metformin hydrochloride when given together with cisplatin and external beam radiation therapy in treating participants with stage III-IV head and neck squamous cell cancer. Eight different companies were represented as sponsors in the trials, with nine studies sponsored by MNCs. Below is a list of selected clinical trials that are currently open and recruiting, but you can expand or narrow your search. Bramante et al. Lou et al, Am J Trop Med, adults with diabetes in China, OR for survival: 4.36 (1.22-15.59). Genetic and Rare Diseases Information Center. Clinical trials are research studies that involve people. Diabetes clinical trials are an essential way for the medical research profession to understand more about diabetes and how it affects us. Participants in the PEP cohort of the trial are those who do not test positive for SARS-COV-2 infection at the time of screening but had a close exposure to SARS-CoV-2 infected person (defined by current CDC definition of close contact). If certain medical tests, such as an X-ray scan, for example, make you uncomfortable, ask in advance if those or other procedures will be part of the clinical trial. A SARS-CoV-2 protein interaction map reveals targets for drug repurposing. Metformin, a drug typically used for the treatment of diabetes, may help to reduce the growth of cancerous tumor cells in participants with malignant solid tumors. MNCs have played a significant role in the clinical trials of metformin FDCs. Type1 diabetes usually develops in children or young adults and requires daily insulin to survive. External beam radiation therapy uses high-energy beams to kill tumor cells and shrink tumors. The clinical trials on this list are studying Metformin Hydrochloride. This drug is inexpensive, has an excellent safety profile, and can be safely combined with other antidiabetes agents (2). ClinicalTrials.gov Identifier: NCT04510194, Interventional Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, This phase III trial studies how well metformin hydrochloride works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Type 1 diabetes —includes studies funded by the NIH or other U.S. Government agencies Aims/hypothesis: The aim of this study was to compare the efficacy and safety of once-weekly albiglutide with once-daily insulin glargine (A21Gly,B31Arg,B32Arg human insulin) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea. Metformin hydrochloride is a widely-used type II diabetes drug that may also stop cancer cells from dividing. (Gordon et al, Nature). All trials on the list are supported by NCI. Six observational studies have found decreased severity of Covid-19 disease among persons with metformin use before diagnosis with Covid-19: Kow, J Med Virol conducted a meta analysis, with an overall odds ratio for mortality of 0.62 (0.43-0.89). Giving metformin, nelfinavir, and bortezomib may work better in treating patients with multiple myeloma. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 infection can prevent emergency department utilization for Covid-19. Giving metformin hydrochloride, cisplatin and external beam radiation therapy may work better at treating head and neck squamous cell cancer. : Estimated Glomerular Filtration Rate (eGFR) of < 45ml/min/1.73 m2, Other kidney disease that in the opinion of the investigator would affect clearance, Electronic medical record history of severe liver disease, Other liver disease that in the opinion of the investigator, would affect metformin clearance, Documented AST or ALT > 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record), Enrollment in another blinded RCT for COVID, Patients taking these medications: cimetidine, hydroxychloroquine, insulin, sulfonylurea, dolutegravir, patiromer, ranolazine, tafenoquine. Please remove one or more studies before adding more. Diabetes Mellitus Type 2 Clinical Trials. You may want to think about taking part in a clinical trial. People with type 2 diabetes who develop COVID-19 show a substantially reduced risk of dying if they are taking metformin, shows a new study that adds to prior research … For Covid-19 Symptoms (as defined by current CDC definition of Covid-19 symptoms). This is a substudy with laboratory outcomes (70 patients will be enrolled). A study in 180 patients from across the United States with type 1 diabetes and COVID-19 included 43% […] discovered the clinical usefulness of metformin while working in Paris. Participants in this arm and group will receive the metformin. Metformin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. If metformin acts to prevent the development of chemoresistance, it is unlikely to have an impact on pancreatic cancer, which, unlike ovarian and lung … Mechanisms of anti-cancer action Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The clinical trials on this list are studying Metformin Hydrochloride. Under review, in adults with non-alcoholic fatty liver disease and +SARS-CoV-2, OR for admission: 0.42 (0.18-1.01, p=0.05). Scientist report that patients with Type 1 diabetes who become infected with the COVID19 may develop a diabetes complication known as ketoacidosis. Gordon DE, Jang GM, Bouhaddou M, Xu J, Obernier K, White KM, O'Meara MJ, Rezelj VV, Guo JZ, Swaney DL, Tummino TA, Hüttenhain R, Kaake RM, Richards AL, Tutuncuoglu B, Foussard H, Batra J, Haas K, Modak M, Kim M, Haas P, Polacco BJ, Braberg H, Fabius JM, Eckhardt M, Soucheray M, Bennett MJ, Cakir M, McGregor MJ, Li Q, Meyer B, Roesch F, Vallet T, Mac Kain A, Miorin L, Moreno E, Naing ZZC, Zhou Y, Peng S, Shi Y, Zhang Z, Shen W, Kirby IT, Melnyk JE, Chorba JS, Lou K, Dai SA, Barrio-Hernandez I, Memon D, Hernandez-Armenta C, Lyu J, Mathy CJP, Perica T, Pilla KB, Ganesan SJ, Saltzberg DJ, Rakesh R, Liu X, Rosenthal SB, Calviello L, Venkataramanan S, Liboy-Lugo J, Lin Y, Huang XP, Liu Y, Wankowicz SA, Bohn M, Safari M, Ugur FS, Koh C, Savar NS, Tran QD, Shengjuler D, Fletcher SJ, O'Neal MC, Cai Y, Chang JCJ, Broadhurst DJ, Klippsten S, Sharp PP, Wenzell NA, Kuzuoglu-Ozturk D, Wang HY, Trenker R, Young JM, Cavero DA, Hiatt J, Roth TL, Rathore U, Subramanian A, Noack J, Hubert M, Stroud RM, Frankel AD, Rosenberg OS, Verba KA, Agard DA, Ott M, Emerman M, Jura N, von Zastrow M, Verdin E, Ashworth A, Schwartz O, d'Enfert C, Mukherjee S, Jacobson M, Malik HS, Fujimori DG, Ideker T, Craik CS, Floor SN, Fraser JS, Gross JD, Sali A, Roth BL, Ruggero D, Taunton J, Kortemme T, Beltrao P, Vignuzzi M, García-Sastre A, Shokat KM, Shoichet BK, Krogan NJ. Assessed with Symptom Scale Recommended by FDA for Industry 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. In a 16-week randomised clinical trial involving 390 individuals with type 2 diabetes, compared with placebo, the addition of metformin to insulin therapy (basal/bolus regimens) resulted in superior glycaemic control, improved HbA 1c (6.9% [51.9 mmol/mol] vs 7.6% [59.6 mmol/mol], metformin+insulin vs placebo; both from baselines of approximately 7.9% [62.8 mmol/mol]; p < … Metformin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A clinical trial is a way to carefully test a new drug or device in patients before it is approved by the FDA to be used in the general public. article The VA IMPACT trial is currently evaluating metformin versus placebo among patients without diabetes and is powered for cardiovascular outcomes. Lilly posts results of all registered Lilly-sponsored clinical trials. This is one of the primary outcomes for the stage 1 trial. American Kennel Club Canine Health Foundation, Inc. 8051 Arco Corporate Dr. Suite 300 Raleigh, NC 27617 (888)-682-9696. The use of metformin hydrochloride may prevent breast cancer. Outpatient metformin use has now been associated with lower IL-6, CRP, and neutrophil-lymphocyte ratio in persons with Covid-19. The intervention is metformin, a biguanide, administered in its immediate release formation, 1,500mg daily. Metformin hydrochloride is primarily used to treat and prevent type 2 diabetes. Before diabetes treatments are used to treat patients, their effects must be carefully tested in clinical phases. Metformin; immediate release formation; 1,500mg daily. The purpose of this trial is to conduct a Stage 1 Substudy powered to detect a difference in continuous laboratory outcomes: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly spreading viral infection causing COVID-19 disease. All trials on the list are supported by NCI. Participants in this arm and group will receive placebo. +PCR) within 3 days of randomization; negative antibody test not required. Metformin was also effective at weight loss and reduction in blood pressure. Epub 2020 Apr 30. Learn more about the study here: Pet owners with pets that meet study […] Metformin hydrochloride may prevent or lower risk of breast cancer and decrease cancer cells, lower risk of cancer spreading. Under review, in adults with Covid-19, OR for admission 0.46 (0.27-0.80), p<0.01; mortality, OR 0.49 (0.26-0.94); and metformin was associated with lower IL-6 (non-significant) lower neutrophil/lymphocyte ratio and CPR, and equivalent lactate and bicarbonate as non-metformin. Gordon et al found decreased SARS-CoV-2 and increased cell viability with metformin in vitro. As a result, it has become the most widely prescribed antidiabetes drug worldwide. 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