Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Diabetes Mellitus
Interventions
DRUG

AC2993 (exenatide)

Dose-escalation beginning with 2.5 μg administered subcutaneously twice per day (BID); then to 2.5 μg four times a day (QID); then to 5 μg four times a day; then to 10 μg four times a day.

DRUG

daclizumab (immunosuppressive)

2 mg/kg intravenously infused over 30 minutes every month for 12 months

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

AstraZeneca

INDUSTRY