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Elixir Pharmaceuticals Announces Clinical Data at American Diabetes,Association Conference Highlighting Ability of Glufast to Maintain,Glycemic Control in Patients with Type 2 Diabetes

percent of patients enrolled had been receiving one OHA treatment prior to their enrollment in this study, but their baseline glycemic control was insufficient. Institute Servier sponsored the study, which was conducted at major diabetes and gerontology centers in the UK, Australia, France, Poland, Russia, Brazil, and Mexico.

The results of the study demonstrated glycemic control was managed better by Glufast than by acarbose. After six months, HbA1c levels (a standard means of assessing chronic elevated blood glucose levels) were 7.43 +/- 1.03 in patients receiving Glufast and 7.75 +/- 1.47 in patients receiving acarbose (ITT, p less than 0.001).

Major hypoglycemia events did not occur in either arm. Minor hypoglycemic events were reported in 7.6 percent of patients receiving Glufast(R). In patients receiving acarbose, 22 percent withdrew due to adverse effect withdrawals, primarily gastrointestinal effects. In the Glufast arm, 10 percent of patients withdrew due to adverse effects, 3.3 percent of which were due to hypoglycemia.

The second study examined the potential efficacy of adding Glufast(R) to metformin for the treatment of patients with T2DM. Metformin has become the standard for initiation of OHA therapy after diet and exercise fail to control HbA1c levels. The Institute Servier-sponsored trial, which took place in Australia and New Zealand, enrolled 324 T2DM patients who had received metformin for a minimum of four months. The patients then were assigned randomly to continue metformin, receive metformin with titrated doses of Glufast, or to switch to Glufast alone. Baseline glycemic control was inadequate in all groups. The primary endpoint of this trial was continued or improved control of HbA1c.

The results of the study demonstrated glycemic control was improved by the combination of Glufast and metformin with HbA1c levels at 7 months being 7.13 +/- 0.82 compared with 7.70 +/- 0.86 in the metformin alone arm. Major hypoglycem
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