Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
The purpose of this study is to compare the effectiveness of two different kinds of diabetes
 medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar
 levels with little or no weight gain in patients with type 2 diabetes who are not well
 controlled on two or more oral (by mouth) diabetes medications. Both medications are given by
 injection with a very small needle just below the surface of your skin (called subcutaneous
 injection). The medication that you inject will be in addition to your oral medications.
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.
Inclusion Criteria:

 1. A diagnosis of Type 2 DM for over six months

 2. A history of inadequate glycemic control (A1c > 7.5% but < 10%) despite treatment with
 2 or more oral hypoglycemic agents

 3. 18 years of age or older

 4. Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major
 mental illness during the previous 6 months)

 5. Naïve to insulin (no insulin for more than 14 days during the previous 6 months and
 none within 60 days of beginning the study)

 6. On at least ½ maximum or the greatest tolerable dose of their oral agents according to
 the label for at least 3 months

 7. BMI < 40 kg/m2

 8. Willing to perform at least four finger stick blood glucose measurements each day

 Exclusion Criteria:

 1. A diagnosis of Type 2 DM for less than six months

 2. An A1c of < 7.5% or > 10%

 3. Pregnancy as determined by a serum ß HCG.

 4. An unstable medical status

 5. Taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the
 course of the study

 6. Inability to read and write English

 7. Someone who is not likely to return for the follow-up because they or their sponsor is
 likely to have a permanent change of station or termination of service before
 completion of the protocol

 8. Unwilling to perform four finger stick blood glucose measurements each day

 9. Previous history of use of exenatide