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NCT01721382 · ClinicalTrials.gov registry record · Phase 1
Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
A Phase 1 study of Cystic Fibrosis, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01721382: Completed Phase 1 study of Cystic Fibrosis, sponsored by Nemours Children's Clinic.
NCT01721382 is a Phase 1 study of Cystic Fibrosis that has completed, run by Nemours Children's Clinic. The registered enrollment target is 6 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721382, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at baseline and again \~4 weeks after treatment with study drug. We will also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before each time the MMTT/OGTT are performed. Several hormones that may affect the way the body regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine has on the hormones measured during the OGTT and MMTT.
Primary Outcome
Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.
Conditions Studied
Interventions
- DRUG Sitagliptin
Study Locations (1)
Florida
- Nemours Children's Clinic - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT01721382 record still lists
NCT01721382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Sitagliptin is the first listed.
NCT01721382 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01721382 about?
NCT01721382 is a clinical study titled "Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis". This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at basel...
What is the current status of trial NCT01721382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-11. Estimated completion is 2016-06.
What conditions does trial NCT01721382 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01721382?
The interventions under investigation include: Sitagliptin (DRUG).
Who is sponsoring clinical trial NCT01721382?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01721382 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01721382's enrollment target sits among peer trials
6 168th of 169 higher than 1 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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