Sanford Research/USD proposes to study the combination therapy of oral administration of sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells still present in patients with recent-onset diabetes and possibly regenerating their beta cells, while safely down-regulating the autoimmune response directed against the beta cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
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
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.
Rady Children's Hospital
San Diego, California, United States
Children's - St. Paul
Saint Paul, Minnesota, United States
Sanford Research/USD
Sioux Falls, South Dakota, United States
2 Hour C-peptide AUC in Response to MMTT
Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.
Time frame: Month 12
2 Hour C-peptide AUC in Response to MMTT
Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.
Time frame: Month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.