Cystic FibrosisPhase 2NCT01257464
Sitagliptin in Cystic Fibrosis-Related Diabetes
A Phase 2 study testing Sitagliptin in people with Cystic Fibrosis, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Jun 2012
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or older
- Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy
Who cannot join
- Age under 19 years
- Use of basal insulin therapy
- Creatinine Clearance < 50 mL/min
- Active cystic fibrosis exacerbation
- Pregnancy
- Women of child-bearing age not using effective contraception
- Current or prior use of DPPIV inhibitor
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)
Vancouver, British Columbia, V5Z 1L8
About this study
Official title: The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes
The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.
Read the detailed description
To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.
- Conditions
- Cystic Fibrosis
- Being tested
- Sitagliptin, Placebo
- Keywords
- CFRD, sitagliptin, cystic fibrosis-related diabetes, incretins, hyperglycemia, GIP, GLP-1
- Medical subject headings
- Cystic Fibrosis, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
100mg po one dose
PlaceboDrug
Sugar pill po one dose
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin release
The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
Measured: 180 minutes (during clamp)
Secondary outcomes (1)
Incretin Response
We will assess incretin release [glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)] during the glucose clamp.
Measured: 180 minutes (during clamp)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Lack of recruitment
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graydon Meneilly, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257464
- Sponsor's protocol ID
- H08-02131
- Status last verified
- Mar 2014
- First submitted
- 2 Dec 2010
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes
- ClinicalTrials.gov ID
- NCT01257464
- Acronym / sponsor ID
- H08-02131
- Conditions
- Cystic Fibrosis
- Keywords
- CFRD, sitagliptin, cystic fibrosis-related diabetes, incretins, hyperglycemia, GIP, GLP-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Dec 2010 (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.
The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.
Detailed description
To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: Sitagliptin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 19 years of age or older
- Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy
Key exclusion criteria (7 listed)
- Age under 19 years
- Use of basal insulin therapy
- Creatinine Clearance < 50 mL/min
- Active cystic fibrosis exacerbation
- Pregnancy
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 |
|---|---|---|
| SitagliptinAlso: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)100mg po one dose | Drug | Sitagliptin |
| PlaceboSugar pill po one dose | Drug | Placebo |
Primary outcome
Insulin release
Time frame: 180 minutes (during clamp)
The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
1 secondary outcome
Incretin Response
Time frame: 180 minutes (during clamp)
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
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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.
Graydon Meneilly, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitagliptin in people with Cystic Fibrosis, run by University of British Columbia at 1 site in Canada.
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 2 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: stopped early, as of the sponsor's last update on 6 Mar 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Insulin release (time frame: 180 minutes (during clamp)). 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 6 Mar 2014.