Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

May 31, 2014

Study Completion Date

March 31, 2015

Conditions
Type 1 Diabetes
Interventions
DRUG

Sitagliptin and Lansoprazole

"Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) or matching placebo~* Subjects age 11-17 years at Visit 2 will take 1 capsule once daily~* Subjects age 18-45 years at Visit 2 will take 2 capsules once daily"

DRUG

Placebo

Sitagliptin 50mg and Lansoprazole 30 mg or matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.

Trial Locations (3)

55102

Children's - St. Paul, Saint Paul

57104

Sanford Research/USD, Sioux Falls

92123-4282

Rady Children's Hospital, San Diego

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Sanford Health

OTHER