NCT01155284

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

Combination Therapy With Sitagliptin (DPP 4 Inhibitor) and Lansoprazole (PPI) Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Sanford Health · Academic / Other
• Sex: All
• Age: 11 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-05-01
• Completion: 2015-03-01
• First posted: 2010-07-01
• Last updated: 2017-09-18
• Results posted: 2017-09-18

Locations

3 sites across 1 country: United States