Cystic FibrosisPhase 3PreventNCT00967798
Prevention of Cystic Fibrosis Diabetes
A Phase 3 study testing Sitagliptin in people with Cystic Fibrosis and Prediabetes, run by Emory University at 3 sites in United States.
Trial summary
Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing cells, and thus worsen glucose intolerance. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cystic Fibrosis, Prediabetes
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to 31 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 13 years of age or older at the time of enrollment
- Diagnosis of cystic fibrosis (CF) confirmed by pilocarpine iontophoresis sweat chloride measurements and/or genotyping
- Clinically stable with no lower respiratory tract exacerbation requiring intravenous antibiotics in the three weeks prior to enrollment
- On a stable clinical treatment regimen for at least three weeks prior to enrollment
- Male or female. If female, is not lactating and has a negative pregnancy test at screening. If female of child bearing potential, willing to practice effective birth control (i.e. a method known to decrease the risk of pregnancy to less than 1%)
- Able to understand and provide informed consent
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- Willing and able to comply with the study schedule and testing
- High risk prediabetes as defined by high-risk impaired fasting glucose levels of 110-125 mg/dl and/or a 2-hour plasma glucose level of 140 to 199 mg/dl found on an Oral Glucose Tolerance Test performed at screening 8 weeks or less before enrollment
- Available by telephone
- Has literacy and language skills required to fill out study material
Who cannot join
- Diagnosed with CF related diabetes
- Chronic heart failure with New York Heart Association (NYHA) class III/IV, ejection fraction less than 25%, or receiving digoxin
- Liver disease as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) three times above the upper limit of normal.
- Serum creatinine greater than 1.3 mg/dl for males and greater than 1.1 mg/dl for females or receiving chronic dialysis
- Taking chronic oral or intravenous glucocorticosteroids during the past month
- On insulin therapy during the past month
Show all 15Show fewer
- CF lung disease severe enough to require daytime chronic oxygen therapy via nasal cannula during the past month
- Unable to perform pulmonary function testing
- History of any illness or condition that, in the opinion of the sponsor might confound the results of the study or pose an additional risk in administering study drug to the subject
- Post lung or liver transplant
- Listed and awaiting organ transplant
- Current drug or alcohol dependency
- Participating in another clinical drug trial or past participant within 30 days of enrollment
- Pancreatic sufficient
- History of acute pancreatitis as documented by characteristic clinical manifestations and elevation of serum amylase and lipase within the last 2 years.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University and Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of Diabetes
Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing cells, and thus worsen glucose intolerance. Patients with cystic fibrosis (CF) have a high prevalence of CF related diabetes (CFRD) and up to 40% of CF adults develop CFRD. During the prediabetic phase in CF, there is progression from normal glucose homeostasis to high risk prediabetes characterized by episodes of acute hyperglycemia after meals and during respiratory exacerbations. The mild hyperglycemia seen in CF patients with high risk prediabetes following a meal would be expected to induce a degree of systemic inflammation and oxidative stress. These repetitive episodes, if left unchecked, could lead to progression of glucose impairment, worsening severity of oxidative stress and inflammation, and ultimately the development of CFRD, all via hyperglycemia-induced toxicity to beta cells. Furthermore, this process may be accelerated in CF because lung disease and resultant respiratory exacerbations are associated with oxidative stress and inflammation and this will further contribute to beta cell damage.
Sitagliptin is a recently approved agent for type 2 diabetes and markedly enhances insulin secretion in the presence of hyperglycemia and has been shown to be effective in preventing postprandial hyperglycemia. The hypothesis to be tested in this project is that sitagliptin will prevent the development of CFRD in CF subjects with high risk prediabetes by blocking postprandial hyperglycemia. The investigators propose a randomized, double-blind, placebo-controlled, multicenter, 15-month longitudinal study in 118 CF subjects with high risk prediabetes to test this hypothesis. Specifically, the investigators aim to show that chronic treatment with sitagliptin: prevents the conversion to diabetes; results in preservation of beta cell function; reduces systemic measures of oxidative stress and inflammation; and slows the rate of progression of lung disease.
Funding Source - FDA Office of Orphan Products Development
Read the detailed description
This was a double-blind, placebo-controlled, multicenter study intending to enroll 118 CF subjects aged 13 years of age or older who have high risk prediabetes. High risk prediabetes was defined during the screening visit by performing an oral glucose tolerance test (OGTT) and finding that the fasting plasma glucose level is between 110-125 mg/dl and/or the 2-hour plasma glucose level is between 140 and 199 mg/dl. Upon enrollment, subjects were randomized to receive either sitagliptin or placebo. Each subject was to be followed for 15 months to determine if sitagliptin prevented the conversion to frank diabetes.
The following was to be done at enrollment and every 6 months: an OGTT with collection of blood at 0, 1/2, and 2 hours for measurement of glucose and insulin in order to determine progression of glucose intolerance; collection of blood at time 0 and 2 hours during the OGTT and measurement of systemic redox status, oxidative stress, and degree of inflammation to determine the degree of basal oxidative stress and inflammation as well as the degree of hyperglycemia-induced oxidative stress and inflammation; collection of exhaled breath condensate in a subset of subjects at selected sites at time 0 and 2 hours during the OGTT and measurement of airway redox status, degree of inflammation, and glucose levels to determine basal respiratory tract redox status and inflammation, the degree of hyperglycemia-induced changes in redox status and inflammation, and correlation between plasma and airway glucose levels; collection of blood to determine safety of the study medication (liver and renal function, complete blood count, electrolyte concentrations); and determination of progression of lung disease as defined by the number of respiratory exacerbations severe enough to require hospitalization and the rate of decline in lung function.
The results of two OGTTs performed at least one week apart was used to determine whether the subject had converted from high risk prediabetes to frank diabetes (primary objective). Conversion to CFRD was defined when both OGTTs were abnormal (abnormal is defined as a fasting plasma glucose level greater than 125 mg/dl and/or a 2 hour glucose level greater than 199 mg/dl). The results of measures of redox balance, oxidant stress and inflammation (secondary objectives) would provide biologic plausibility to our concept on the mechanism of action of sitagliptin in preventing the development of CF diabetes.
Hemoglobin-specific A1c fraction (HbA1c) was to be measured half-way between the 6-monthly visits and a rise of more than 0.5% from the enrollment value would result in two OGTT tests done at least one week apart to determine if diabetes has developed. At these interval study visits, blood was also collected to assess the safety of the study drug and, if the subject was female, to determine if pregnancy had occurred.
In the event that diabetes did develop, the study drug (or placebo) was to be stopped and the subject would have completed the study.
In summary, this was a double-blind, placebo-controlled clinical trial to determine whether sitagliptin prevents the conversion of CF subjects with high-risk prediabetes to frank diabetes. If successful, this would be the first treatment modality available to prevent the development of CFRD, a serious and life shortening complication of CF. Unfortunately, the study sites were unable to achieve enrollment targets and the study was prematurely terminated March 31, 2017 because of low enrollment. For those subjects enrolled in the study, there was no safety concerns. Data are currently being analyzed for the subjects that were enrolled.
- Conditions
- Cystic Fibrosis, Prediabetes
- Being tested
- Sitagliptin
- Keywords
- cystic fibrosis, diabetes, inflammation, oxidative stress, redox balance, lung disease
- Medical subject headings
- Cystic Fibrosis, Prediabetic State, Diabetes Mellitus, Inflammation, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
100 mg of sitagliptin is taken orally each morning with breakfast. Duration is 12 months or conversion to CF diabetes, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | CF patients receiving Sitagliptin.
Intervention: Dose is 100 mg taken orally once a day in the morning with breakfast. Duration is one year or until converted to CF diabetes, whichever comes sooner. Receives: Drug: Sitagliptin |
| Sugar pill | Placebo comparator | CF patients receiving placebo.
Intervention: Placebo is taken orally once a day in the morning with breakfast. Duration is one year or until converted to CF diabetes, whichever comes sooner. Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Conversion to Cystic Fibrosis Related Diabetes
The number of participants with conversion to cystic fibrosis related diabetes was determined.
Measured: Month 15
Secondary outcomes (4)
Change in Beta-cell Disposition Index
Preservation of beta-cell function was to be assessed with the disposition index, which is a measurement of beta-cell function adjusted for insensitivity to insulin.
Measured: Baseline through Month 15
Change in Redox Couples Glutathione/Glutathione Disulfide and Cysteine/Cystine
Cysteine (Cys)/cystine (CySS) and glutathione (GSH)/glutathione disulfide (GSSG) redox couples are biomarkers of oxidative stress.
Measured: Baseline through Month 12
Change in Inflammatory Cytokines
Hyperglycemia causes release of pro-inflammatory cytokines which can further compromise beta-cell function by increasing insulin resistance and by inducing beta-cell apoptosis. Inflammatory cytokines that have been shown to contribute to destruction of beta-cells include interleukin 1 beta (IL-1b), tumor necrosis factor alpha (TNFa), and interleukin 6 (IL-6).
Measured: Baseline through Month 12
Change in Percent Predicted FEV1
The decline of lung function was assessed with forced expiratory volume (FEV1), which measures how much air is exhaled during one second of a forced exhale. Change is described as the difference in FEV1 at baseline subtracted from FEV1 at the end of treatment study visit. A protocol change during the study reduced the treatment time from 24 months to 12 months. The end of treatment study visit for participants in the early part of the study occurred at 24 months, while the end of treatment visit was a 12 months for participants enrolling later. Negative values indicate a decline in lung function over the course of the study.
Measured: Baseline, end of treatment (Month 12 or Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startMay 2010
- Primary completion31 Mar 2017
- Study completion31 Dec 2017
Why it stopped: Could not achieve target enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlene Stecenko, Emory University
- Investigators
- Arlene A Stecenko, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967798
- Sponsor's protocol ID
- IRB00012724
- Other IDs
- 1R01FD003527-01
- Acronym
- Prevent
- Status last verified
- Apr 2018
- First submitted
- 27 Aug 2009
- Last updated
- 25 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of Diabetes
- ClinicalTrials.gov ID
- NCT00967798
- Acronym / sponsor ID
- Prevent / IRB00012724
- Conditions
- Cystic Fibrosis, Prediabetes
- Keywords
- cystic fibrosis, diabetes, inflammation, oxidative stress, redox balance, lung disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not achieve target enrollment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 25 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing cells, and thus worsen glucose intolerance. Patients with cystic fibrosis (CF) have a high prevalence of CF related diabetes (CFRD) and up to 40% of CF adults develop CFRD. During the prediabetic phase in CF, there is progression from normal glucose homeostasis to high risk prediabetes characterized by episodes of acute hyperglycemia after meals and during respiratory exacerbations. The mild hyperglycemia seen in CF patients with high risk prediabetes following a meal would be expected to induce a degree of systemic inflammation and oxidative stress. These repetitive episodes, if left unchecked, could lead to progression of glucose impairment, worsening severity of oxidative stress and inflammation, and ultimately the development of CFRD, all via hyperglycemia-induced toxicity to beta cells. Furthermore, this process may be accelerated in CF because lung disease and resultant respiratory exacerbations are associated with oxidative stress and inflammation and this will further contribute to beta cell damage.
Sitagliptin is a recently approved agent for type 2 diabetes and markedly enhances insulin secretion in the presence of hyperglycemia and has been shown to be effective in preventing postprandial hyperglycemia. The hypothesis to be tested in this project is that sitagliptin will prevent the development of CFRD in CF subjects with high risk prediabetes by blocking postprandial hyperglycemia. The investigators propose a randomized, double-blind, placebo-controlled, multicenter, 15-month longitudinal study in 118 CF subjects with high risk prediabetes to test this hypothesis. Specifically, the investigators aim to show that chronic treatment with sitagliptin: prevents the conversion to diabetes; results in preservation of beta cell function; reduces systemic measures of oxidative stress and inflammation; and slows the rate of progression of lung disease.
Funding Source - FDA Office of Orphan Products Development
Detailed description
This was a double-blind, placebo-controlled, multicenter study intending to enroll 118 CF subjects aged 13 years of age or older who have high risk prediabetes. High risk prediabetes was defined during the screening visit by performing an oral glucose tolerance test (OGTT) and finding that the fasting plasma glucose level is between 110-125 mg/dl and/or the 2-hour plasma glucose level is between 140 and 199 mg/dl. Upon enrollment, subjects were randomized to receive either sitagliptin or placebo. Each subject was to be followed for 15 months to determine if sitagliptin prevented the conversion to frank diabetes.
The following was to be done at enrollment and every 6 months: an OGTT with collection of blood at 0, 1/2, and 2 hours for measurement of glucose and insulin in order to determine progression of glucose intolerance; collection of blood at time 0 and 2 hours during the OGTT and measurement of systemic redox status, oxidative stress, and degree of inflammation to determine the degree of basal oxidative stress and inflammation as well as the degree of hyperglycemia-induced oxidative stress and inflammation; collection of exhaled breath condensate in a subset of subjects at selected sites at time 0 and 2 hours during the OGTT and measurement of airway redox status, degree of inflammation, and glucose levels to determine basal respiratory tract redox status and inflammation, the degree of hyperglycemia-induced changes in redox status and inflammation, and correlation between plasma and airway glucose levels; collection of blood to determine safety of the study medication (liver and renal function, complete blood count, electrolyte concentrations); and determination of progression of lung disease as defined by the number of respiratory exacerbations severe enough to require hospitalization and the rate of decline in lung function.
The results of two OGTTs performed at least one week apart was used to determine whether the subject had converted from high risk prediabetes to frank diabetes (primary objective). Conversion to CFRD was defined when both OGTTs were abnormal (abnormal is defined as a fasting plasma glucose level greater than 125 mg/dl and/or a 2 hour glucose level greater than 199 mg/dl). The results of measures of redox balance, oxidant stress and inflammation (secondary objectives) would provide biologic plausibility to our concept on the mechanism of action of sitagliptin in preventing the development of CF diabetes.
Hemoglobin-specific A1c fraction (HbA1c) was to be measured half-way between the 6-monthly visits and a rise of more than 0.5% from the enrollment value would result in two OGTT tests done at least one week apart to determine if diabetes has developed. At these interval study visits, blood was also collected to assess the safety of the study drug and, if the subject was female, to determine if pregnancy had occurred.
In the event that diabetes did develop, the study drug (or placebo) was to be stopped and the subject would have completed the study.
In summary, this was a double-blind, placebo-controlled clinical trial to determine whether sitagliptin prevents the conversion of CF subjects with high-risk prediabetes to frank diabetes. If successful, this would be the first treatment modality available to prevent the development of CFRD, a serious and life shortening complication of CF. Unfortunately, the study sites were unable to achieve enrollment targets and the study was prematurely terminated March 31, 2017 because of low enrollment. For those subjects enrolled in the study, there was no safety concerns. Data are currently being analyzed for the subjects that were enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinCF patients receiving Sitagliptin. Intervention: Dose is 100 mg taken orally once a day in the morning with breakfast. Duration is one year or until converted to CF diabetes, whichever comes sooner. |
| Sugar pill | Placebo comparator | Drug: SitagliptinCF patients receiving placebo. Intervention: Placebo is taken orally once a day in the morning with breakfast. Duration is one year or until converted to CF diabetes, whichever comes sooner. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 13 years of age or older at the time of enrollment
- Diagnosis of cystic fibrosis (CF) confirmed by pilocarpine iontophoresis sweat chloride measurements and/or genotyping
- Clinically stable with no lower respiratory tract exacerbation requiring intravenous antibiotics in the three weeks prior to enrollment
- On a stable clinical treatment regimen for at least three weeks prior to enrollment
- Male or female. If female, is not lactating and has a negative pregnancy test at screening. If female of child bearing potential, willing to practice effective birth control (i.e. a method known to decrease the risk of pregnancy to less than 1%)
Key exclusion criteria (15 listed)
- Diagnosed with CF related diabetes
- Chronic heart failure with New York Heart Association (NYHA) class III/IV, ejection fraction less than 25%, or receiving digoxin
- Liver disease as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) three times above the upper limit of normal.
- Serum creatinine greater than 1.3 mg/dl for males and greater than 1.1 mg/dl for females or receiving chronic dialysis
- Taking chronic oral or intravenous glucocorticosteroids during the past month
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: Januvia100 mg of sitagliptin is taken orally each morning with breakfast. Duration is 12 months or conversion to CF diabetes, whichever comes first. | Drug | Sitagliptin, Sugar pill |
Primary outcome
Number of Participants With Conversion to Cystic Fibrosis Related Diabetes
Time frame: Month 15
The number of participants with conversion to cystic fibrosis related diabetes was determined.
4 secondary outcomes
Change in Beta-cell Disposition Index
Time frame: Baseline through Month 15
Change in Redox Couples Glutathione/Glutathione Disulfide and Cysteine/Cystine
Time frame: Baseline through Month 12
Change in Inflammatory Cytokines
Time frame: Baseline through Month 12
Change in Percent Predicted FEV1
Time frame: Baseline, end of treatment (Month 12 or Month 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Arlene A Stecenko, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin in people with Cystic Fibrosis and Prediabetes, run by Emory University at 3 sites 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 10 inclusion and 15 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Conversion to Cystic Fibrosis Related Diabetes (time frame: Month 15). 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 25 Jun 2018.