Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes

The sodium‐dependent glucose transporter 2 (SGLT2) inhibitor remogliflozin etabonate (RE) was evaluated in a 12‐week, double‐blind, randomized, placebo‐ and active‐controlled, parallel‐group study. A total of 252 newly diagnosed and drug‐naïve people with type 2 diabetes and glycated haemoglobin (Hb...

Full description

Saved in:

Bibliographic Details
Published in:	Diabetes, obesity & metabolism Vol. 17; no. 1; pp. 98 - 101
Main Authors:	Sykes, A. P., Kemp, G. L., Dobbins, R., O'Connor-Semmes, R., Almond, S. R., Wilkison, W. O., Walker, S., Kler, L.
Format:	Journal Article
Language:	English
Published:	Oxford, UK Blackwell Publishing Ltd 01-01-2015 Wiley Subscription Services, Inc
Subjects:	Body weight Cholesterol Cohort Studies Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug therapy Follow-Up Studies Glucose transporter Glucosides - administration & dosage Glucosides - adverse effects Glucosides - therapeutic use glycaemic control Glycated Hemoglobin A - analysis Hemoglobin Humans Hyperglycemia - prevention & control Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Intention to Treat Analysis Low density lipoprotein Membrane Transport Modulators - administration & dosage Membrane Transport Modulators - adverse effects Membrane Transport Modulators - therapeutic use Middle Aged Patient Dropouts Pioglitazone Placebos Prodrugs - administration & dosage Prodrugs - adverse effects Prodrugs - therapeutic use Pyrazoles - administration & dosage Pyrazoles - adverse effects Pyrazoles - therapeutic use remogliflozin etabonate SGLT2 Sodium-glucose cotransporter Sodium-Glucose Transporter 2 - antagonists & inhibitors Statistical analysis Thiazolidinediones - administration & dosage Thiazolidinediones - adverse effects Thiazolidinediones - therapeutic use type 2 diabetes Weight Loss - drug effects glycaemic control type 2 diabetes remogliflozin etabonate SGLT2
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	The sodium‐dependent glucose transporter 2 (SGLT2) inhibitor remogliflozin etabonate (RE) was evaluated in a 12‐week, double‐blind, randomized, placebo‐ and active‐controlled, parallel‐group study. A total of 252 newly diagnosed and drug‐naïve people with type 2 diabetes and glycated haemoglobin (HbA1c) concentrations of 7.0–≤9.5% (53–80 mmol/mol) were recruited. Participants were randomized to RE (100, 250, 500 or 1000 mg once daily or 250 mg twice daily), placebo or 30 mg pioglitazone once daily. The primary endpoint was change in HbA1c concentration from baseline. Secondary endpoints included changes in fasting plasma glucose, body weight and lipid profiles, safety and tolerability. We observed a statistically significant trend in the RE dose–response relationship for change from baseline in HbA1c at week 12 (p < 0.047). RE was generally well tolerated and no effects on LDL cholesterol were observed.
Bibliography:	ark:/67375/WNG-FSC9B747-D istex:8FB85A5BD07EA2CCFAB9C1B20DF90770F9E13FA3 Figure S1. Mean change in glycated haemoglobin concentration from baseline (±standard error) for each visit (LOCF) in the intent-to-treat population.Figure S2. Mean change in fasting plasma glucose concentrations from baseline (±standard error) for each visit (LOCF) in the intent-to-treat population.Figure S3. Mean change in body weight from baseline (±standard error) for each visit (LOCF) in the intent-to-treat population.Table S1. Participant disposition (all participants).Table S2. Summary of demographic characteristics (intent-to-treat population).Table S3. Summary of most common (≥5% participants in any group) on-therapy adverse events by treatment (safety population). ArticleID:DOM12393 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	1462-8902 1463-1326
DOI:	10.1111/dom.12393