Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Diabetes Type 2
Interventions
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.

Trial Locations (2)

20003

MedStar Research Institute, Washington D.C.

20306

Walter Reed Army Medical Center, Washington D.C.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

BodyMedia

UNKNOWN

lead

Novo Nordisk A/S

INDUSTRY

NCT01076842 - Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment | Biotech Hunter | Biotech Hunter