Before diabetes treatments are used to treat patients, their effects must be carefully tested in clinical phases. (Gordon et al, Nature). Gordon et al found decreased SARS-CoV-2 and increased cell viability with metformin in vitro. Researchers think that metformin may reduce the risk of getting prostate cancer or may even be able to treat it. Metformin, a biguanide derived from the French lilac, has become the preferred first-line therapy for the treatment of type 2 diabetes (1). Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. discovered the clinical usefulness of metformin while working in Paris. 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. The fully powered trial is a parallel enrolling treatment and post-exposure prophylaxis trial. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Metformin has about 24 times less reported incidents of lactic acidosis compared with phenformin. What does the clinical trial consist of? Electronic medical record history of kidney disease, i.e. For general information, Learn About Clinical Studies. Clinical trials for Metformin hydrochloride Trials with a EudraCT protocol (141) Paediatric studies in scope of Art45 of the Paediatric Regulation (0) 141 result (s) found for: Metformin hydrochloride. In contrast, clinical trials of metformin in pancreatic cancer did not show a survival benefit . MNCs have played a significant role in the clinical trials of metformin FDCs. The study will evaluate 3,000 people over a course of six years. The clinical trials on this list are studying Metformin Hydrochloride. Participants in this arm and group will receive the metformin. Location: 3 locations, This phase I trial studies the side effects and best dose of metformin and nelfinavir in combination with bortezomib in treating patients with multiple myeloma that has come back or does not respond to treatment. DRI clinical trials offer participants the opportunity to play an active role in the diabetes research process and to access potential new therapies before they are widely available. Nature. Tax ID# 13-3813813 Participants in this arm and group will receive the placebo. Clinical trials are research studies that involve people. 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. 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. U.S. Department of Health and Human Services. The use of metformin hydrochloride may prevent breast cancer. 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. This is a substudy with laboratory outcomes (70 patients will be enrolled). GFR>45ml/min within 2 weeks of enrollment, Patient has medical record visible within the EHR of participating sites, BMI >= 25kg/m2 by self-report height/weight or >= 23kg/m2 in patients who self-identify in S. Asian or Latinx background.59-61, Willing and able to comply with study procedures, Has an address and electronic device for communication. 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. 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. Inclusion Criteria, Stage 1 Treatment Trial: Exclusion Criteria, Stage 1 Treatment Trial: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 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 < … Listing a study does not mean it has been evaluated by the U.S. Federal Government. Giving metformin hydrochloride, cisplatin and external beam radiation therapy may work better at treating head and neck squamous cell cancer. 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. Location: 12 locations, This pilot phase II trial studies how well metformin hydrochloride works in treating patients with chronic lymphocytic leukemia that has come back or untreated chronic lymphocytic leukemia with genomic deletion 11q. But before finding this out they need to know how and why metformin affects prostate cancer. 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. 2020 Jul;583(7816):459-468. doi: 10.1038/s41586-020-2286-9. It is not yet known whether giving metformin hydrochloride together with doxycycline may be a better way in treating patients with localized breast, uterine, or cervical cancer. Giving metformin, nelfinavir, and bortezomib may work better in treating patients with multiple myeloma. Eighteen of the 25 published clinical trials conducted in patients with type 2 diabetes disclosed sponsor funding or were conducted by pharmaceutical companies. Clinical trials are research studies that involve people. 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. Participants in this arm and group will receive placebo. ], Incidence of hospitalization for Covid-19. 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. Type 2 diabetes occurs when the pancreas is unable to produce insulin within the body, resulting in hyperglycemia. 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. If metformin acts to prevent the development of chemoresistance, it is unlikely to have an impact on pancreatic cancer, which, unlike ovarian and lung … You may want to think about taking part in a clinical trial. Symptom onset greater than 7 days before randomization (symptoms not required for inclusion). Metformin use started in France in 1957, but it was not introduced in the United States until 1995, nearly 20 years after the biguanide phenformin was taken off the market because of its risk of lactic acidosis, which was often fatal." Doxycycline may stop the growth of bacteria by keeping them from making proteins and minimized the toxic side effects of anti-cancer therapy. There currently is no preventive or outpatient treatment therapy for Covid-19. 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. Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. As a result, it has become the most widely prescribed antidiabetes drug worldwide. The intervention is metformin, a biguanide, administered in its immediate release formation, 1,500mg daily. Metformin suppresses colorectal aberrant crypt foci in a short-term clinical trial. Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (i.e. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Estrogen may cause cancer. Cariou et al, Diabetologia, adults with diabetes (DM) in France: OR mortality 0.59 (0.42, 0.84), Crouse et al, medrxiv.org adults with DM at Univ of Alabama Birmingham: OR mortality 0.33 (0.13-0.84). 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. This drug is inexpensive, has an excellent safety profile, and can be safely combined with other antidiabetes agents (2). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. What clinical trials for diabetes are open? The effect of the drug was so striking that doctors in Cambridge are now planning a clinical trial of MS patients next year. This is one of the primary outcomes for the stage 1 trial. Bramante et al. ClinicalTrials.gov Identifier: NCT04510194, Interventional A study in 180 patients from across the United States with type 1 diabetes and COVID-19 included 43% […] Genetic and Rare Diseases Information Center. Diabetes Mellitus Type 2 Clinical Trials. Metformin hydrochloride is a widely-used type II diabetes drug that may also stop cancer cells from dividing. 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. This is one of the primary outcomes for the stage 1 trial. 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