75
Participants
Start Date
April 30, 2008
Primary Completion Date
April 30, 2011
Study Completion Date
April 30, 2011
Insulin-Levemir
Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
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.
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.
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
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.
MedStar Research Institute, Washington D.C.
Walter Reed Army Medical Center, Washington D.C.
Lead Sponsor
BodyMedia
UNKNOWN
Novo Nordisk A/S
INDUSTRY