Results from a study indicating that Exenatide ( Byetta ) injection showed sustained improvements in blood glucose control and progressive weight reduction through a year and a half of therapy for people with type 2 diabetes failing to achieve acceptable blood glucose control on Metformin and/or a sulfonylurea, two common oral diabetes medications.

The data also show improvements in markers associated with cardiovascular risk factors, including lipids and blood pressure.

Byetta, is the first in a new class of medicines known as incretin mimetics, and was approved by the Food and Drug Administration on April 28, 2005 for the treatment of type 2 diabetes.

" Findings from these long-term data demonstrate that Byetta has unique benefits for patients with type 2 diabetes who had previously struggled to manage the disease effectively," said David Kendall, at the International Diabetes Center in Minneapolis, and a principal investigator for Byetta clinical studies.

Close to 90 percent of patients completing 30 weeks of therapy in the Byetta pivotal studies elected to continue in an open-label extension where all patients received 10 micrograms of Byetta twice a day.

Data collected over 82 weeks among 265 patients demonstrated that long-term administration of Byetta in combination with Metformin, a sulfonylurea or both, results in sustained reductions in blood glucose and progressive reductions in weight.

Patients demonstrated an average reduction of 1.2 percent in A1C levels, a measure reflecting a person's average blood sugar over a three-month period.
The average starting A1C for these patients was 8.3 percent. These same patients also demonstrated reductions in body weight, with an average weight reduction of 4.6 kilograms or 10.1 pounds.
The benefits associated with weight reduction are particularly significant given that many therapies for type 2 diabetes cause weight gain.

In addition to improvements in glucose control and weight, administration of Byetta for 82 weeks resulted in clinically meaningful improvements in cardiovascular risk factors. These included clinically positive changes associated with HDL cholesterol, triglycerides, and blood pressure.

In general, improvements in cardiovascular risk factors appeared greatest in patients who experienced the greatest weight reduction.

Side effects, which were predominantly gastrointestinal in nature, were consistent with those observed in patients during the placebo-controlled trials. No new safety signals were observed.

To evaluate the durability of effect of Byetta at the highest dose tested, the subset of patients who had received 10 micrograms of Byetta for two years was also examined.
In the 146 patients who completed two years of treatment on 10 micrograms in combination with Metformin and/or a sulfonylurea, the average reduction in A1C from baseline was 1.2 percent with average reductions in body weight of 5.5 kilograms or 12.1 pounds.

Adverse events associated with Byetta are generally mild to moderate in intensity. In clinical trials, the most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy, the frequency and severity of nausea decreased over time in most patients.
Patients receiving Byetta in combination with a sulfonylurea may be at a higher risk of hypoglycemia, or low blood sugar. To reduce this risk, lowering the sulfonylurea dosage may be considered.
Byetta may lead to a reduction in appetite, food intake, and/or body weight, and that there is no need to modify the dosing regimen due to such effects.

Byetta is not a substitute for insulin in insulin-requiring patients.

Byetta should not be used in patients with type 1 diabetes.
Use of Byetta is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease.
Byetta should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.

Source: American Diabetes Association ( ADA ) 65th Annual Scientific Sessions, 2005


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