NCT01076842

Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment

The Effect of Detemir Compared to Exenatide and/or the Combination of Detemir and Exenatide on Glycemic Control and Weight in Patients With Type 2 Diabetes Mellitus Who Have Failed Oral Hypoglycemic Agents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Type 2

Interventions

Type	Name	Description
DRUG	Insulin-Levemir	Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
DRUG	Exenatide-Bayetta	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.
DRUG	Insulin-Levemir and Exenatide-Bayetta	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.
DEVICE	SenseWear Pro3® armband	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
DEVICE	DexCom CGM	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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-02-26
• Last updated: 2011-06-27

Locations

2 sites across 1 country: United States