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NCT01155284 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Sanford Health.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT01155284: Completed Phase 2 study, sponsored by Sanford Health.

NCT01155284 is a Phase 2 study that has completed, run by Sanford Health. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01155284, a Phase 2 study, has completed, sponsored by Sanford Health.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study 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.

Primary Outcome

Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.

Interventions

  • DRUG Placebo
  • DRUG Sitagliptin and Lansoprazole

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2010-08
Est. Completion 2015-03
Phase Phase 2
Sanford Health

34 total trials

What the finished NCT01155284 record still lists

NCT01155284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01155284 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01155284 about?

NCT01155284 is a clinical study titled "Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes". 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-regula...

What is the current status of trial NCT01155284?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2010-08. Estimated completion is 2015-03.

What interventions are being tested in trial NCT01155284?

The interventions under investigation include: Placebo (DRUG), Sitagliptin and Lansoprazole (DRUG).

Who is sponsoring clinical trial NCT01155284?

This trial is sponsored by Sanford Health, which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01155284's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01155284, the US trial registry maintained by the National Library of Medicine. NCT01155284 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.