Cystic FibrosisPhase 1NCT01721382
Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
A Phase 1 study testing Sitagliptin in people with Cystic Fibrosis, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with CF between 13 and <21 yrs old
- Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
- No history of CFRD
Who cannot join
- Insulin use in the last two months
- Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
- History of pancreatitis in the last 12 months
- Skin rashes or conditions that may affect CGM placement and wear
- Pregnancy or intent on becoming pregnant
- Patients on growth hormone therapy
- Renal insufficiency with creatinine clearance <50 ml/min (based on Schwartz formula)
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
Official title: 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 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Sitagliptin
- Keywords
- cystic fibrosis, CF, CFRD, sitagliptin, incretins, GLP1, GIP, beta cell function, adolescents
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | Treatment with sitagliptin Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to sitagliptin
Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.
Measured: Change from baseline to ~4 weeks of study drug
Response to sitagliptin
Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.
Measured: Change from baseline to ~4 weeks of study drug
Response to sitagliptin
Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.
Measured: Change from baseline to ~4 weeks of study drug
Response to sitagliptin
Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.
Measured: Change from baseline to ~4 weeks of study drug
Secondary outcomes (2)
Beta-cell function
Beta-cell function will be measured using mixed meal tolerance tests (MMTT) and oral glucose tolerance tests (OGTT), assessing maximum concentration and area under the curve (AUC) of glucose, insulin and c-peptide for both OGTT and MMTT.
Measured: Change from baseline to ~4 weeks of study drug
Continuous glucose monitoring (CGM)
Baseline and post-treatment changes in glycemic variability using CGM, including mean amplitude of glycemic excursion (MAGE), peak post-prandial blood sugars, and glucose area under the curve.
Measured: change from baseline to ~4 weeks of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Fox, Nemours Children's Clinic
- Investigators
- Larry A Fox, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721382
- Sponsor's protocol ID
- CFRD-01
- Status last verified
- Jun 2016
- First submitted
- 26 Oct 2012
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01721382
- Acronym / sponsor ID
- CFRD-01
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, CF, CFRD, sitagliptin, incretins, GLP1, GIP, beta cell function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinTreatment with sitagliptin |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with CF between 13 and <21 yrs old
- Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
- No history of CFRD
Key exclusion criteria (7 listed)
- Insulin use in the last two months
- Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
- History of pancreatitis in the last 12 months
- Skin rashes or conditions that may affect CGM placement and wear
- Pregnancy or intent on becoming pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin | Drug | Sitagliptin |
Primary outcome
Response to sitagliptin
Time frame: Change from baseline to ~4 weeks of study drug
Baseline and stimulated C-peptide levels (using mixed meal tolerance test) before and after treatment with sitagliptin.
Response to sitagliptin
Time frame: Change from baseline to ~4 weeks of study drug
Change in glycemic variability using continuous glucose monitoring data before and after treatment with dipeptidyl peptidase-4 inhibitor.
Response to sitagliptin
Time frame: Change from baseline to ~4 weeks of study drug
Change in incretins concentrations (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) in response to study drug.
Response to sitagliptin
Time frame: Change from baseline to ~4 weeks of study drug
Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.
2 secondary outcomes
Beta-cell function
Time frame: Change from baseline to ~4 weeks of study drug
Continuous glucose monitoring (CGM)
Time frame: change from baseline to ~4 weeks of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry A Fox, MD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sitagliptin in people with Cystic Fibrosis, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to sitagliptin (time frame: Change from baseline to ~4 weeks of study drug). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.