| Canagliflozin Improves Glycemic Control Over 28 Days in Subjects With Type 2 Diabetes Not Optimally Controlled on Insulin. | |
| | |
MedLine Citation:
|
PMID: 22226086 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
Aims: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is being investigated for the treatment of type 2 diabetes mellitus (T2DM). Methods: This was a randomized, double-blind, placebo-controlled, parallel-group, 28-day study conducted at 2 sites, in 29 subjects with T2DM not optimally controlled on insulin and up to 1 oral antihyperglycemic agent. Subjects were treated with canagliflozin 100 mg QD or 300 mg BID or placebo. Safety, tolerability, pharmacokinetic characteristics and pharmacodynamic effects of canagliflozin were examined. Glucose malabsorption following a 75-g oral glucose challenge was also examined. Results: Canagliflozin pharmacokinetics were dose-dependent, and the elimination half-life ranged from 12-15 hours. After 28 days, the renal threshold for glucose excretion was reduced; urinary glucose excretion was increased; and A1C, fasting plasma glucose, and body weight decreased in subjects administered canagliflozin (A1C reductions: 0.19% with placebo, 0.73% with 100 mg QD, 0.92% with 300 mg BID; body weight changes: 0.03 kg increase with placebo, 0.73 kg reduction with 100 mg QD, 1.19 kg reduction with 300 mg BID). Glucose malabsorption was not observed with canagliflozin treatment. There were no deaths, serious adverse events, or severe hypoglycemic episodes. The incidence of adverse events was similar across groups. There were no clinically meaningful changes in routine laboratory safety tests, vital signs, or electrocardiograms. Conclusion: In subjects receiving insulin and oral antihyperglycemic therapy, canagliflozin was well tolerated without evidence for glucose malabsorption, had pharmacokinetic characteristics consistent with once-daily dosing, and improved glycemic control. |
| | |
Authors:
|
D Devineni; L Morrow; M Hompesch; D Skee; A Vandebosch; J Murphy; Kirk Ways; S Schwartz |
Related Documents
:
|
19534826 - Parental diabetes status reveals association of mitochondrial dna haplogroup j1 with ty... 11978666 - 5' flanking variants of resistin are associated with obesity. 11286636 - Ctla4 gene polymorphisms are associated with, and linked to, insulin-dependent diabetes... 16644636 - The effects of the pro12ala polymorphism of the peroxisome proliferator-activated recep... 17612646 - Mitochondrial membrane fluidity, potential, and calcium transients in the myocardium fr... 15081316 - Paradoxical downregulation of the glucose oxidation pathway despite enhanced flux in se... |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2012-1-6 |
Journal Detail:
|
Title: Diabetes, obesity & metabolism Volume: - ISSN: 1463-1326 ISO Abbreviation: - Publication Date: 2012 Jan |
Date Detail:
|
Created Date: 2012-1-9 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 100883645 Medline TA: Diabetes Obes Metab Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
© 2012 Blackwell Publishing Ltd. |
Affiliation:
|
Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan NJ, USA Profil Institute for Clinical Research, Chula Vista, CA, USA Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium DGD Research, San Antonio, TX, USA. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Synthesis, structure, DNA-binding properties and antioxidant activity of a nickel(II) complex with b...
Next Document: Comparative meta-analysis of adefovir dipivoxil monotherapy and combination therapy of adefovir dipi...