Clinical trial NCT04626089 - References

Type 2 Diabetes — Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2

Citation(s)

•   Borza CM, Borza DB, Pedchenko V, Saleem MA, Mathieson PW, Sado Y, Hudson HM, Pozzi A, Saus J, Abrahamson DR, Zent R, Hudson BG
  Human podocytes adhere to the KRGDS motif of the alpha3alpha4alpha5 collagen IV network. J Am Soc Nephrol. 2008 Apr;19(4):677-8
•   Cataldo NA, Abbasi F, McLaughlin TL, Basina M, Fechner PY, Giudice LC, Reaven GM
  Metabolic and ovarian effects of rosiglitazone treatment for 12 weeks in insulin-resistant women with polycystic ovary syndrome. Hum Reprod. 2006 Jan;21(1):109-20. Epub 2005
•   Catanzaro N, Meng XJ
  Induction of the unfolded protein response (UPR) suppresses porcine reproductive and respiratory syndrome virus (PRRSV) replication. Virus Res. 2020 Jan 15;276:197820. doi: 10.1016/j.virusres.2019.197820. Epub 2019 Nov 16.
•   Choi YH, Lee MG
  Effects of enzyme inducers and inhibitors on the pharmacokinetics of metformin in rats: involvement of CYP2C11, 2D1 and 3A1/2 for the metabolism of metformin. Br J Pharmacol. 2006 Oct;149(4):424-30. Epub 2006 Aug 29.
•   Cuthbertson J, Patterson S, O'Harte FP, Bell PM
  Investigation of the effect of oral metformin on dipeptidylpeptidase-4 (DPP-4) activity in Type 2 diabetes. Diabet Med. 2009 Jun;26(6):649-54. doi: 10.1111/j.1464-5491.2009.02748.x.
•   Darris C, Revert F, Revert-Ros F, Gozalbo-Rovira R, Feigley A, Fidler A, Lopez-Pascual E, Saus J, Hudson BG
  Unicellular ancestry and mechanisms of diversification of Goodpasture antigen-binding protein. J Biol Chem. 2019 Jan 18;294(3):759-769. doi: 10.10
•   Detaille D, Guigas B, Leverve X, Wiernsperger N, Devos P
  Obligatory role of membrane events in the regulatory effect of metformin on the respiratory chain function. Biochem Pharmacol. 2002 Apr 1;63(7):1259-72.
•   Dianben® 1000 mg polvo para solución oral
  Ficha técnica del producto. Nº de autorización de comercialización: 70545. Merck Santé S.A.S. 37 rue Saint Romain. 69008 Lyon. Francia. Fecha de revision 2010. Consultada en la web de la Agencia Española del Medi
•   Féry F, Plat L, Balasse EO
  Effects of metformin on the pathways of glucose utilization after oral glucose in non-insulin-dependent diabetes mellitus patients. Metabolism. 1997 Feb;46(2):227-33.
•   Fischer M, Timper K, Radimerski T, Dembinski K, Frey DM, Zulewski H, Keller U, Müller B, Christ-Crain M, Grisouard J
  Metformin induces glucose uptake in human preadipocyte-derived adipocytes from various fat depots. Diabetes Obes Metab. 2010 Apr;12(4):35
•   Food Chem Toxicol
  2019 Jan;123:470-480. doi: 10.1016/j.fct.2018.11.019. Epub 2018 Nov 9.
•   Foretz M, Hébrard S, Leclerc J, Zarrinpashneh E, Soty M, Mithieux G, Sakamoto K, Andreelli F, Viollet B
  Metformin inhibits hepatic gluconeogenesis in mice independently of the LKB1/AMPK pathway via a decrease in hepatic energy state. J Clin Invest. 2010
•   Fung TS, Liu DX
  Human Coronavirus: Host-Pathogen Interaction. Annu Rev Microbiol. 2019 Sep 8;73:529-557. doi: 10.1146/annurev-micro-020518-115759. Epub 2019 Jun 21. Review.
•   Garza-Ocañas L, Tamez-de la O E, Iglesias-Chiesa J, Gonzalez Canudas J, Rivas-Ruiz R: Pharmacokinetics and gastrointestinal tolerability of DMMET 01 (glycinate of metformin): results of a prospective randomized trial in healthy volunteers [abstract]
  Diab
•   Giugliano D, De Rosa N, Di Maro G, Marfella R, Acampora R, Buoninconti R, D'Onofrio F
  Metformin improves glucose, lipid metabolism, and reduces blood pressure in hypertensive, obese women. Diabetes Care. 1993 Oct;16(10):1387-90.
•   Glucophage Product Monograph (metformin hydrochloride) Sanofi-Aventis Canada
  Rev.28th October 2008
•   González-Ortiz M, Martínez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Durán C, González-Canudas J
  Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097. Epub 2012 Sep 13. Efficacy and Safety of Metformin Glycinate vs. Me
•   Granero F, Revert F, Revert-Ros F, Lainez S, Martínez-Martínez P, Saus J
  A human-specific TNF-responsive promoter for Goodpasture antigen-binding protein. FEBS J. 2005 Oct;272(20):5291-305.
•   Hanada K, Kumagai K, Yasuda S, Miura Y, Kawano M, Fukasawa M, Nishijima M
  Molecular machinery for non-vesicular trafficking of ceramide. Nature. 2003 Dec 18;426(6968):803-9.
•   Hother-Nielsen O, Schmitz O, Andersen PH, Beck-Nielsen H, Pedersen O
  Metformin improves peripheral but not hepatic insulin action in obese patients with type II diabetes. Acta Endocrinol (Copenh). 1989 Mar;120(3):257-65.
•   Hudson BG, Tryggvason K, Sundaramoorthy M, Neilson EG
  Alport's syndrome, Goodpasture's syndrome, and type IV collagen. N Engl J Med. 2003 Jun 19;348(25):2543-56. Review.
•   JORGE GONZÁLEZ-CANUDAS, COMET GROUP Diabetes Efficacy and Safety of Metformin Glycinate vs
  Metformin Hydrochloride in Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Mellitus Patients. Diabetes 2019 Jun; 68(Supplement 1):
•   Landin K, Tengborn L, Smith U
  Treating insulin resistance in hypertension with metformin reduces both blood pressure and metabolic risk factors. J Intern Med. 1991 Feb;229(2):181-7.
•   Landman GW, Kleefstra N, van Hateren KJ, Groenier KH, Gans RO, Bilo HJ
  Metformin associated with lower cancer mortality in type 2 diabetes: ZODIAC-16. Diabetes Care. 2010 Feb;33(2):322-6. doi: 10.2337/dc09-1380. Epub 2009 Nov 16.
•   Musi N, Hirshman MF, Nygren J, Svanfeldt M, Bavenholm P, Rooyackers O, Zhou G, Williamson JM, Ljunqvist O, Efendic S, Moller DE, Thorell A, Goodyear LJ
  Metformin increases AMP-activated protein kinase activity in skeletal muscle of subjects with type 2 d
•   NDA 20-357, Glucophage
  US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
•   NDA 21-842, Actoplus met
  US Food and Drug Administration. Center for Drug Evaluation and Research. Freedom of Information Office. New Drug Approval Packages. Pharmacology/Toxicology Review.
•   Nichols GA, Gomez-Caminero A
  Weight changes following the initiation of new anti-hyperglycaemic therapies. Diabetes Obes Metab. 2007 Jan;9(1):96-102.
•   Otto M, Breinholt J, Westergaard N
  Metformin inhibits glycogen synthesis and gluconeogenesis in cultured rat hepatocytes. Diabetes Obes Metab. 2003 May;5(3):189-94.
•   Quaile MP, Melich DH, Jordan HL, Nold JB, Chism JP, Polli JW, Smith GA, Rhodes MC
  Toxicity and toxicokinetics of metformin in rats. Toxicol Appl Pharmacol. 2010 Mar 15;243(3):340-7. doi: 10.1016/j.taap.2009.11.026. Epub 2010 Jan 13.
•   Quinones S, Bernal D, García-Sogo M, Elena SF, Saus J
  Exon/intron structure of the human alpha 3(IV) gene encompassing the Goodpasture antigen (alpha 3(IV)NC1). Identification of a potentially antigenic region at the triple helix/NC1 domain junction. J B
•   Rada P, Mosquera A, Muntané J, Ferrandiz F, Rodriguez-Mañas L, de Pablo F, González-Canudas J, Valverde ÁM
  Differential effects of metformin glycinate and hydrochloride in glucose production, AMPK phosphorylation and insulin sensitivity in hepatocytes fr
•   Raya A, Revert-Ros F, Martinez-Martinez P, Navarro S, Rosello E, Vieites B, Granero F, Forteza J, Saus J
  Goodpasture antigen-binding protein, the kinase that phosphorylates the goodpasture antigen, is an alternatively spliced variant implicated in autoim
•   Revert F, Merino R, Monteagudo C, Macias J, Peydró A, Alcácer J, Muniesa P, Marquina R, Blanco M, Iglesias M, Revert-Ros F, Merino J, Saus J
  Increased Goodpasture antigen-binding protein expression induces type IV collagen disorganization and deposit of
•   Revert F, Penadés JR, Plana M, Bernal D, Johansson C, Itarte E, Cervera J, Wieslander J, Quinones S, Saus J
  Phosphorylation of the Goodpasture antigen by type A protein kinases. J Biol Chem. 1995 Jun 2;270(22):13254-61.
•   Revert F, Revert-Ros F, Blasco R, Artigot A, López-Pascual E, Gozalbo-Rovira R, Ventura I, Gutiérrez-Carbonell E, Roda N, Ruíz-Sanchis D, Forteza J, Alcácer J, Pérez-Sastre A, Díaz A, Pérez-Payá E, Sanz-Cervera JF, Saus J
  Selective targeting of collagen
•   Revert F, Ventura I, Martínez-Martínez P, Granero-Moltó F, Revert-Ros F, Macías J, Saus J
  Goodpasture antigen-binding protein is a soluble exportable protein that interacts with type IV collagen. Identification of novel membrane-bound isoforms. J Biol Chem. 2008 Oct 31;283(44):30246-55. doi: 10.1074/jbc.M805026200. Epub 2008 Sep 4.
•   Revert-Ros F, López-Pascual E, Granero-Moltó F, Macías J, Breyer R, Zent R, Hudson BG, Saadeddin A, Revert F, Blasco R, Navarro C, Burks D, Saus J
  Goodpasture antigen-binding protein (GPBP) directs myofibril formation: identification of intracellular dow
•   Santuré M, Pitre M, Gaudreault N, Marette A, Nadeau A, Bachelard H
  Effect of metformin on the vascular and glucose metabolic actions of insulin in hypertensive rats. Am J Physiol Gastrointest Liver Physiol. 2000 May;278(5):G682-92.
•   Saus J, Wieslander J, Langeveld JP, Quinones S, Hudson BG
  Identification of the Goodpasture antigen as the alpha 3(IV) chain of collagen IV. J Biol Chem. 1988 Sep 15;263(26):13374-80.
•   Schimmack G, Defronzo RA, Musi N
  AMP-activated protein kinase: Role in metabolism and therapeutic implications. Diabetes Obes Metab. 2006 Nov;8(6):591-602. Review.
•   Shaw RJ, Lamia KA, Vasquez D, Koo SH, Bardeesy N, Depinho RA, Montminy M, Cantley LC
  The kinase LKB1 mediates glucose homeostasis in liver and therapeutic effects of metformin. Science. 2005 Dec 9;310(5754):1642-6. Epub 2005 Nov 24.
•   Sriwijitkamol A, Musi N
  Advances in the development of AMPK-activating compounds. Expert Opin Drug Discov. 2008 Oct;3(10):1167-76. doi: 10.1517/17460441.3.10.1167.
•   Standeven KF, Ariëns RA, Whitaker P, Ashcroft AE, Weisel JW, Grant PJ
  The effect of dimethylbiguanide on thrombin activity, FXIII activation, fibrin polymerization, and fibrin clot formation. Diabetes. 2002 Jan;51(1):189-97.
•   Stumvoll M, Nurjhan N, Perriello G, Dailey G, Gerich JE
  Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N Engl J Med. 1995 Aug 31;333(9):550-4.
•   Swanton C, Marani M, Pardo O, Warne PH, Kelly G, Sahai E, Elustondo F, Chang J, Temple J, Ahmed AA, Brenton JD, Downward J, Nicke B
  Regulators of mitotic arrest and ceramide metabolism are determinants of sensitivity to paclitaxel and other chemotherapeu
•   Szegezdi E, Logue SE, Gorman AM, Samali A
  Mediators of endoplasmic reticulum stress-induced apoptosis. EMBO Rep. 2006 Sep;7(9):880-5. Review.
•   Tamura Y, Watada H, Sato F, Kumashiro N, Sakurai Y, Hirose T, Tanaka Y, Kawamori R
  Effects of metformin on peripheral insulin sensitivity and intracellular lipid contents in muscle and liver of overweight Japanese subjects. Diabetes Obes Metab. 2008 Sep;
•   Verma S, Bhanot S, McNeill JH
  Antihypertensive effects of metformin in fructose-fed hyperinsulinemic, hypertensive rats. J Pharmacol Exp Ther. 1994 Dec;271(3):1334-7.

Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.

Details for clinical trial NCT04626089