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08-11-2011 | Diabetes | Article

Remogliflozin etabonate well tolerated and effective in treating diabetes

Abstract

Free abstract

MedWire News: Remogliflozin etabonate (RE), a sodium glucose transporter 2 (SGLT2) inhibitor, is well tolerated and effective in reducing plasma glucose in Type 2 diabetes patients, researchers show.

The drug also reduces body weight and blood pressure, they say.

Single doses of RE have previously been shown to increase urinary glucose excretion (UGE) in Type 2 diabetes patients, reports the team.

Therefore, to examine the efficacy, safety and tolerability of repeated doses of RE, Robert Dobbins (GlaxoSmithKline, North Carolina, USA) and colleagues recruited 36 individuals with diabetes to take part in a study investigating the effects of RE use over a 12-day period.

The participants were assigned sequentially into three cohorts of 12 people. In each cohort, the individuals were randomly assigned to RE (n=9) or matching placebo (n=3) for 12 days. The RE doses were 100 mg twice-daily (every 12 hours, before breakfast and dinner), 1000 mg once-daily (before breakfast), and 1000 mg twice-daily.

As reported in the journal Diabetes, Obesity and Metabolism, all three RE regimens significantly decreased 24-hour plasma glucose concentrations.

Compared with the placebo group, the 24-hour mean reductions in plasma glucose on day 11 for RE 100 mg twice daily, 1000 mg once-daily, and 1000 mg twice-daily were 1.2 mmol/L, 0.8 mmol/L, and 1.7 mmol/L, respectively.

The UGE in those receiving RE was also significantly increased on day 11, relative to baseline and placebo.

The mean absolute amount of glucose excreted in the urine over the 24-hour period on day 11 was 29 mmol for the placebo group compared with 509 mmol in the RE 100 mg twice-daily group, 918 mmol in the RE 1000 mg once-daily group, and 574 mmol in the RE 1000 mg twice-daily group.

No serious adverse events were reported.

In addition, the mean weight loss observed at the end of the trial ranged from 2.3 to 4.5 kg in the RE groups versus 1.6 kg in the placebo group.

All three RE treatment groups also showed a trend towards decreased blood pressure compared with placebo, although this was only significant in the 1000 mg once-daily group.

The authors say the results complement a report showing glucose lowering in individuals with Type 2 diabetes for a separate selective SGLT2 inhibitor, dapagliflozin, for which administration of single daily doses 5 mg, 25 mg, and 100 mg for 14 days resulted in mean changes in fasting glucose of 1.0 mmol/L, 1.6 mmol/L, and 2.2 mmol/L, respectively.

"Additional long-term studies of SGLT2 inhibitors are required to fully understand the safety implications of their use for the treatment of Type 2 diabetes," write Dobbins et al.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

By Sally Robertson