Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment.

Finding a safe and effective method of improving blood glucose (BG) control without weight
gain is one of the major goals of diabetes research. Previous research studies have shown
that Levemir and Byetta are safe and effective medications in the treatment of type 2
diabetes. Both drugs have been approved by the U.S. Food and Drug Administration (FDA) for
the treatment of type 2 diabetes. The use of Levemir and Byetta in combination in this
study, is investigational, meaning it is not approved by the FDA for this use. However, the
FDA has allowed the use of Levemir and Byetta in combination in this study of safety and
effectiveness in improving blood sugar levels with little or no weight gain in people with
type 2 diabetes.

Levemir is a long acting insulin that is usually taken once a day at bedtime and can last
for up to 24 hours. Unlike most insulins that lower blood glucose levels, but cause weight
gain, clinical research trials suggest that Levemir may lower blood glucose levels without
causing weight gain and may even result in weight loss.

Byetta is not insulin, but improves blood glucose control by mimicking the action of
hormones in the gastrointestinal tract called incretins. The incretin hormones trigger the
release of insulin from the pancreas and allow insulin to work more effectively in the body.
Byetta also delays the movement of food from the stomach into the small intestine. As a
result, people taking Byetta may feel "full" faster and longer, so they eat less. The most
common side effect with Byetta is mild to moderate nausea, which improves with time in most
people. Clinical research trials that have studied the effects of Byetta have shown that, in
addition to lowering blood glucose levels, the use of Byetta resulted in weight loss.

There have been no previous studies that have compared Levemir to Byetta in patients who
have failed to achieve blood glucose goals with two or three oral diabetes medications.