CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Sitagliptin and Lansoprazole +1 moredrug
Likely dose
Sitagliptin and Lansoprazole 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01155284
NCT01155284Phase 2Completed
CompareCT.gov

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

Sanford Health·interventional·Posted Jul 1, 2010·Updated Sep 18, 2017

In Brief

A Phase 2 clinical trial evaluating Sitagliptin and Lansoprazole and Placebo for Type 1 Diabetes. Completed, enrolled 70 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.0 years ago

Interventions

Sitagliptin and Lansoprazoledrug

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

Placebodrug

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.