Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Insulin-Levemir; Exenatide-Bayetta; Insulin-Levemir and Exenatide-Bayetta; SenseWear Pro3® armband; DexCom CGM
Intervention type(s): Drug; Drug; Drug; Device; Device
Intervention description(s): Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl; Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.; Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.; For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data; For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations.
Other intervention name(s): Levemir; Exenatide; Levemir+Exenatide; armband; continuous glucose monitoring
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Exenatide; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes