Abstract
Patients with type 2 diabetes mellitus (T2DM) are characterized by an elevated glycemic index and are at a higher risk for complications such as cardiovascular disease, nephropathy, retinopathy and peripheral neuropathy. Normalization of glycemic index can be achieved by dosing combinations of metformin with other anti-diabetic drugs. The present study (Clintrials number NCT00519480) was conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of remogliflozinetabonate, an SGLT2 inhibitor, withdoses (500 mg and 750 mg BID) greater than the commercial dose (100 mg BID)in combination with metformin with minimum daily dose of 2000 mg given in two divided doses. This was a randomized, double-blinded, repeat dose study in 50 subjects with T2DM. The study was conducted in three phases; run-in, randomization, and treatment. All subjects were on a stable metformin dosing regimen. Cohort 1 subjects were randomly allocated to receive either remogliflozin etabonate 500 mg BID or placebo BID (2:1) in addition to metformin. Cohort 2 subjects were administered with either remogliflozin etabonate 750 mg BID or placebo BID (2:1) in addition to metformin for 13 days. All the subjects were assessed for safety (advers...Continue Reading
References
Aug 8, 2001·British Journal of Clinical Pharmacology·T M DavisP Chubb
Nov 26, 2003·Archives of Internal Medicine·Shelley R SalpeterEdwin E Salpeter
Jul 29, 2006·Diabetes Care·Tao FanSteven J Bowlin
Feb 27, 2009·Journal of Medicinal Chemistry·William N Washburn
Jul 10, 2010·Journal of the American Society of Nephrology : JASN·Volker VallonTimo Rieg
Aug 2, 2012·Drug Metabolism and Disposition : the Biological Fate of Chemicals·James F SigafoosJoseph W Polli
Sep 27, 2012·Diabetes Care·Sunder MudaliarRobert L Dobbins
May 2, 2013·BMC Pharmacology & Toxicology·Elizabeth K HusseyRobert L Dobbins
May 15, 2013·BMC Pharmacology & Toxicology·Anita KapurDerek J Nunez
Jun 20, 2013·Blood Pressure·UNKNOWN Task Force for the management of arterial hypertension of the European Society of Hypertension, UNKNOWN Task Force for the management of arterial hypertension of the European Society of Cardiology
Sep 17, 2014·Diabetes, Obesity & Metabolism·A P SykesL Kler
Sep 23, 2014·Diabetes, Obesity & Metabolism·A P SykesL Kler
Oct 2, 2014·Diabetes Care·Ilkka TikkanenUNKNOWN EMPA-REG BP Investigators
Nov 27, 2014·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Sanjay Kalra
Dec 30, 2014·Diabetes Care·Silvio E InzucchiDavid R Matthews
May 3, 2015·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Robin O'Connor-SemmesWilliam O Wilkison
Aug 20, 2015·Expert Opinion on Investigational Drugs·Nasser Mikhail
Dec 17, 2016·Brazilian Journal of Medical and Biological Research = Revista Brasileira De Pesquisas Médicas E Biológicas·E L AndradeJ B Calixto
Aug 5, 2017·Diabetologia·Graham RenaEwan R Pearson
Mar 16, 2018·Molecular Therapy. Methods & Clinical Development·Beatriz Silva Lima, Mafalda Ascensão Videira
Mar 13, 2020·Drugs·Mala DharmalingamHanmant Barkate